ENT Applicator Suppliers
Limit companies to: Worldwide USA
Clinimed, Inc. | Address: 303 Markus Court, Sandy Brae Industrial Park, Newark, Delaware 19713-1190, USA 
www.clinimed.us | Send Inquiry | Phone: +1-(302)-454-8400
FDA Registration: 2431788 Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO, CE Certified
Products: Tourniquet Machines, Tourniquets, Pneumatic Tourniquet (FDA Code: KCY), Tourniquet System, Tourniquet machines and accessories, Orthopedic tourniquet machines, ...
Clinimed Inc. deals with surgical instruments and medical devices. We supply clinimed tourniquete, halo retractors and vein strippers. We offer online journals such as anesthesiology, cancer, cardiolo more...
www.clinimed.us | Send Inquiry | Phone: +1-(302)-454-8400
FDA Registration: 2431788 Year Established: 1978 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO, CE Certified
Products: Tourniquet Machines, Tourniquets, Pneumatic Tourniquet (FDA Code: KCY), Tourniquet System, Tourniquet machines and accessories, Orthopedic tourniquet machines, ...
Clinimed Inc. deals with surgical instruments and medical devices. We supply clinimed tourniquete, halo retractors and vein strippers. We offer online journals such as anesthesiology, cancer, cardiolo more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
Puritan Medical Products Co. LLC | Address: P.O. Box 149, Guilford, Maine 04443-0149, USA
www.puritanmedproducts.com | Send Inquiry | Phone: +1-(800)-321-2313
FDA Registration: 1216735 Year Established: 1919 Annual Revenues: USD 25-50 Million Employee Count: ~320 Quality: ISO 9000, ISO 9001, CE Certified
Products: Diagnostic Aids, Microbiology Kit, General Diagnostic Supplies, General Medical Supplies, General Urology Supplies, Swabs & Pads, ...
Puritan Medical Products Co. LLC produces single-use products for medical & industrial applications, which include swabs, applicators, tongue depressors & specialty products. Our 25-700 infant tongue more...
www.puritanmedproducts.com | Send Inquiry | Phone: +1-(800)-321-2313
FDA Registration: 1216735 Year Established: 1919 Annual Revenues: USD 25-50 Million Employee Count: ~320 Quality: ISO 9000, ISO 9001, CE Certified
Products: Diagnostic Aids, Microbiology Kit, General Diagnostic Supplies, General Medical Supplies, General Urology Supplies, Swabs & Pads, ...
Puritan Medical Products Co. LLC produces single-use products for medical & industrial applications, which include swabs, applicators, tongue depressors & specialty products. Our 25-700 infant tongue more...
Luxtec | Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
www.luxtec.com | Send Inquiry | Phone: +1-(508)-835-9700
Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito more...
Jedmed Instrument Company | Address: 5416 JEDMED Court, St. Louis, Missouri 63129-2221, USA
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
www.jedmed.com | Send Inquiry | Phone: +1-(314)-845-3770
FDA Registration: 1926681 Annual Revenues: < USD 1 Million Employee Count: ~40 Quality: ISO Certified
Products: Dry Heat Sterilizers (FDA Code: KMH), Laboratory Sterilizers, Endoscopes, Laboratory Steam Sterilizers, Benchtop Steam Sterilizers, Endoscopes, Stabilization and Steering, ...
Jedmed Instrument Company manufactures instruments in the areas of ENT, opthalmology and dentistry. Our endonasal DCR technique uses a fiberoptic probe inserted in the punctum for guidance. Our kaps t more...
Bausch & Lomb | Address: 1400 N. Goodman St., Rochester, New York 14609, USA
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
www.bausch.com | Send Inquiry | Phone: +1-(585)-338-6000, 800-553-5340
FDA Registration: 1920664 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Daily Wear Soft Contact Lenses (FDA Code: LPL), Extended Wear Soft Contact Lenses (FDA Code: LPM), Soft Contact Lense Rinsing Solutions, Soft Contact Lens Storage Solutions, Contact Lens Eye Drops, Soft Contact Lenses For Extended Wear, ...
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life. We offer a comprehensive portfolio of eye health products. Our three broad categories of products are vision more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Aesculap Inc. | Address: 3773 Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
www.aesculapusa.com | Send Inquiry | Phone: +1-(800)-258-1946
FDA Registration: 2916714 Year Established: 1977 Annual Revenues: USD 1-5 Million Employee Count: ~120
Products: Curettes, Drills, Titanium Plating Systems, Suction Tubes, Dural Substitute, Posterior, ...
Aesculap Inc. manufactures surgical instrumentation. Our products include surgical instruments, laparoscopy, endoscopy, neurosurgery, sutrures, surgical quality management, and consulting services. Ou more...
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Amsino International, Inc | Address: 855 Towne Center Drive, Pomona, California 91767, USA
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Adult Tracheostomy Mask, Aspirators, Disposable Leg Bags, Cervical Scrapers, Central Line Dressing Change Trays, Coiled Sterile Suction Catheter, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Adult Tracheostomy Mask, Aspirators, Disposable Leg Bags, Cervical Scrapers, Central Line Dressing Change Trays, Coiled Sterile Suction Catheter, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
NeilMed Pharmaceuticals Inc. | Address: 601 Aviation Blvd., Santa Rosa, California 95403, USA
www.neilmed.com | Send Inquiry | Phone: +1-(707)-5253784
FDA Registration: 2954718
Products: Drug-Free Nasal Irrigation System, ENT Applicator (FDA Code: KCJ), Powered Nasal Irrigator (FDA Code: KMA), Sinus Irrigator (FDA Code: KAR), ...
NeilMed Pharmaceuticals Inc. specializes in offering Sinus Rinse™, nasaflo netipot and nasal irrigation products. Our Sinus Rinse nasal wash is a natural soothing saline nasal wash. A large volu more...
www.neilmed.com | Send Inquiry | Phone: +1-(707)-5253784
FDA Registration: 2954718
Products: Drug-Free Nasal Irrigation System, ENT Applicator (FDA Code: KCJ), Powered Nasal Irrigator (FDA Code: KMA), Sinus Irrigator (FDA Code: KAR), ...
NeilMed Pharmaceuticals Inc. specializes in offering Sinus Rinse™, nasaflo netipot and nasal irrigation products. Our Sinus Rinse nasal wash is a natural soothing saline nasal wash. A large volu more...
Apdyne Medical Company | Address: 1049 South Vine St., Denver, Colorado 80209-4622, USA
www.apdyne.com | Send Inquiry | Phone: +1-(303)-698-4802, 800-457-6853
FDA Registration: 2183861 Year Established: 1989 Annual Revenues: USD 1-5 Million
Products: Topical Anesthesia Applicator (FDA Code: CCT), Applicator, ENT Applicator (FDA Code: KCJ), Phenol Applicator Kits, ...
Apdyne Medical Company is a manufacturer and distributor of the Apdyne phenol applicator kit used to anesthetize the tympanic membrane during in-office myringotomy procedures. It features a fresh unit more...
www.apdyne.com | Send Inquiry | Phone: +1-(303)-698-4802, 800-457-6853
FDA Registration: 2183861 Year Established: 1989 Annual Revenues: USD 1-5 Million
Products: Topical Anesthesia Applicator (FDA Code: CCT), Applicator, ENT Applicator (FDA Code: KCJ), Phenol Applicator Kits, ...
Apdyne Medical Company is a manufacturer and distributor of the Apdyne phenol applicator kit used to anesthetize the tympanic membrane during in-office myringotomy procedures. It features a fresh unit more...
Biomet Microfixation | Address: 1520 Tradeport Dr., Jacksonville, Florida 32218-2480, USA
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
www.biometmicrofixation.com | Send Inquiry | Phone: +1-(904)-741-4400, 800-874-7711
FDA Registration: 1032347 Year Established: 1965
Products: Basic Plastic Surgery Tray, Blepharoplasty Tray, Craniofacial Surgery Tray, Biopsy Trays, Bone Graft Replacement, Angle Blade Plate Instrument, ...
Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic more...
Rece International Corp. | Address: 5881 N.W. 151st St., Ste. 111, Miami Lakes, Florida 33014, USA
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Medafor, Inc. | Address: 2700 Freeway Blvd, Suite 800, Minneapolis, Minnesota 55430, USA
www.medaforinc.com | Send Inquiry | Phone: +1-(877)-6332367
Products: Collagen-Based Non-Absorbable Hemostatic Agent (FDA Code: LMG), General Surgical Manual Instrument (FDA Code: MDM), Liquid Bandage (FDA Code: KMF), Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY), ENT Applicator (FDA Code: KCJ), Drug Wound Dressing (FDA Code: FRO), ...
Medafor, Inc., develops and markets hemostatic technology based on engineered biopolymeric microporous particles. Our products are Arista™AH, FlexiTip™, TraumaDex®, safeseal and Mpatch more...
www.medaforinc.com | Send Inquiry | Phone: +1-(877)-6332367
Products: Collagen-Based Non-Absorbable Hemostatic Agent (FDA Code: LMG), General Surgical Manual Instrument (FDA Code: MDM), Liquid Bandage (FDA Code: KMF), Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY), ENT Applicator (FDA Code: KCJ), Drug Wound Dressing (FDA Code: FRO), ...
Medafor, Inc., develops and markets hemostatic technology based on engineered biopolymeric microporous particles. Our products are Arista™AH, FlexiTip™, TraumaDex®, safeseal and Mpatch more...
Bausch & Lomb Inc. | Address: 8507 Pelham Rd., Greenville, South Carolina 29615-9598, USA
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Phone: +1-(585)-338-6000
FDA Registration: 1032500
Products: Contact Lens (FDA Code: HQD), Contact Lens Case, Container (FDA Code: LRX), ENT Forceps (FDA Code: KAE), Soft Lens Accessories (FDA Code: LPN), Contact Extended Wear Lens (FDA Code: MWL), Contact Lens (Disposable) (FDA Code: MVN), ...
Bausch & Lomb Inc. specializes in offering contact lens and contact lens care products. more...
Gyrus ENT | Address: 2925 Appling Rd, Bartlett, Tennessee 38133, USA
www.retroxhearing.com | Phone: +1-(800)-2623540
FDA Registration: 1037007
Products: Video Otoscopes, Digital Hearing Aids, Surgical Cochlear Implant (FDA Code: MCM), BTE Hearing Aids, Canal Hearing Aids, Industrial, & Specialty Cases, ...
Gyrus ENT deals with otology, sinus and rhinology fields. We offer otology implants, microsurgical instruments, powered dissectors and biomaterials for sinus surgery. Our retrox, a hearing system is d more...
www.retroxhearing.com | Phone: +1-(800)-2623540
FDA Registration: 1037007
Products: Video Otoscopes, Digital Hearing Aids, Surgical Cochlear Implant (FDA Code: MCM), BTE Hearing Aids, Canal Hearing Aids, Industrial, & Specialty Cases, ...
Gyrus ENT deals with otology, sinus and rhinology fields. We offer otology implants, microsurgical instruments, powered dissectors and biomaterials for sinus surgery. Our retrox, a hearing system is d more...
Hydrate, Inc. | Address: 2943 Oak Lake Blvd., Midlothian, Virginia 23112, USA
www.hydrateinc.com | Send Inquiry | Phone: +1-(877)-236-7239
Products: Nasal Cannulas, Humidifiers, Peristaltic Pumps, Clinical Humidifiers, Tracheotomy Instrument, Electrical Nebulizer Pump (FDA Code: JPW), ...
Hydrate, Inc. offers hydrate Omni™ and C-Force™ technology. Our hydrate Omni™ is designed to effectively filter, heat and humidify the air. Depending on ambient conditions, inhaled g more...
www.hydrateinc.com | Send Inquiry | Phone: +1-(877)-236-7239
Products: Nasal Cannulas, Humidifiers, Peristaltic Pumps, Clinical Humidifiers, Tracheotomy Instrument, Electrical Nebulizer Pump (FDA Code: JPW), ...
Hydrate, Inc. offers hydrate Omni™ and C-Force™ technology. Our hydrate Omni™ is designed to effectively filter, heat and humidify the air. Depending on ambient conditions, inhaled g more...
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FDA Code / Regulation: KCJ / 874.5220
An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
