Breathing Mouthpiece Suppliers
Limit companies to: Worldwide USA
Respironics, Inc | Address: #1010, Murry Ridge Lane, Murrysville, Pennsylvania 15668-8525, USA 
www.respironics.com | Send Inquiry | Phone: +1-(724)-387-5200, (800)-345-6443
Year Established: 1976 Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Spirometers, Tubing, Disposables, Capillary Blood Collection Tubes (FDA Code: GIO), ...
Respironics, Inc is a resource for respiratory medical devices. We focus on the diagnosis and treatment of sleep disorders. Our 920M plus handheld pulse oximeter provides on-the-spot blood oximetry an more...
www.respironics.com | Send Inquiry | Phone: +1-(724)-387-5200, (800)-345-6443
Year Established: 1976 Employee Count: ~20 Quality: ISO 9002, CE Certified
Products: Medical Humidifiers, Oxygen Masks (FDA Code: BYG), Spirometers, Tubing, Disposables, Capillary Blood Collection Tubes (FDA Code: GIO), ...
Respironics, Inc is a resource for respiratory medical devices. We focus on the diagnosis and treatment of sleep disorders. Our 920M plus handheld pulse oximeter provides on-the-spot blood oximetry an more...
Amici, Inc. | Address: 518 Vincent St., Spring City, Pennsylvania 19475-1621, USA
www.amici-inc.com | Send Inquiry | Phone: +1-(610)-948-7100
FDA Registration: 2522920 Year Established: 1978 Annual Revenues: < USD 1 Million Quality: IS0 9001, CE Certified
Products: Air Cushion Masks, Mask Harnesses, Aerosol Delivery System, Nose Clips (FDA Code: BXJ), Disposable Spiro Nose Clips, Plastic Nose Clip, Disposable Tourniquet Cuffs, ...
Amici, Inc. is a manufacturer of nuclear lung ventilation products. We produce and distribute diagnostic & therapeutic products for lung ventilation, including masks, mouthpieces, bacteria/virus filte more...
www.amici-inc.com | Send Inquiry | Phone: +1-(610)-948-7100
FDA Registration: 2522920 Year Established: 1978 Annual Revenues: < USD 1 Million Quality: IS0 9001, CE Certified
Products: Air Cushion Masks, Mask Harnesses, Aerosol Delivery System, Nose Clips (FDA Code: BXJ), Disposable Spiro Nose Clips, Plastic Nose Clip, Disposable Tourniquet Cuffs, ...
Amici, Inc. is a manufacturer of nuclear lung ventilation products. We produce and distribute diagnostic & therapeutic products for lung ventilation, including masks, mouthpieces, bacteria/virus filte more...
Alliance Tech Medical, Inc. | Address: PO Box 6024, Granbury, Texas 76049, USA
www.alliancetechmedical.com | Send Inquiry | Phone: +1-(817)-326-6357
FDA Registration: 3004476631
Products: Spirometers, Disposables, Detergents & Bleaches, Disposable Syringes, Hand Cleaners & Disinfectants, General Disinfectants, ...
Alliance Tech Medical, Inc is a developer of respiratory products for the health care industry. Our product line focuses on safety solutions for hospitals, surgery centers, physician offices and clini more...
www.alliancetechmedical.com | Send Inquiry | Phone: +1-(817)-326-6357
FDA Registration: 3004476631
Products: Spirometers, Disposables, Detergents & Bleaches, Disposable Syringes, Hand Cleaners & Disinfectants, General Disinfectants, ...
Alliance Tech Medical, Inc is a developer of respiratory products for the health care industry. Our product line focuses on safety solutions for hospitals, surgery centers, physician offices and clini more...
Unomedical, Inc. | Address: 5701-1 S. Ware Rd, McAllen, Texas 78503, USA
www.unomedical.us | Send Inquiry | Phone: +1-(956)-683-8472
Annual Revenues: USD 50-100 Million Employee Count: ~600 Quality: ISO 9001, ISO 9002, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Face Masks, Dispensing Systems, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code: FAQ), Nebulizers, ...
Unomedical, Inc. specializes in the manufacturing and distribution of medical single-use devices which include anesthesia, respiratory care, urology catheters, electrodes, urine bags, suction catheter more...
www.unomedical.us | Send Inquiry | Phone: +1-(956)-683-8472
Annual Revenues: USD 50-100 Million Employee Count: ~600 Quality: ISO 9001, ISO 9002, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Face Masks, Dispensing Systems, Urinary Leg Bags, Urine Collection Leg Bags (FDA Code: FAQ), Nebulizers, ...
Unomedical, Inc. specializes in the manufacturing and distribution of medical single-use devices which include anesthesia, respiratory care, urology catheters, electrodes, urine bags, suction catheter more...
Myotronics-Normed Inc | Address: 5870 S 194th Street Kent, Tukwila, Washington 98032-2125, USA
www.noromed.com | Phone: +1-(206)-243-4214
FDA Registration: 3013226 Year Established: 1974 Annual Revenues: USD 1-5 Million Employee Count: ~50
Products: Adhesive Strips & Patches, Tubular Elastic Bandages & Nets, Skin Closure Adhesive Strips (FDA Code: FPX), Self Adhesive Strips (FDA Code: FPX), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Myotronics-Normed Inc specializes in designing and manufacturing surface electromyography dynamic range of motion and muscle testing devices. We focus on evaluation & rehabilitation applications in ph more...
www.noromed.com | Phone: +1-(206)-243-4214
FDA Registration: 3013226 Year Established: 1974 Annual Revenues: USD 1-5 Million Employee Count: ~50
Products: Adhesive Strips & Patches, Tubular Elastic Bandages & Nets, Skin Closure Adhesive Strips (FDA Code: FPX), Self Adhesive Strips (FDA Code: FPX), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Myotronics-Normed Inc specializes in designing and manufacturing surface electromyography dynamic range of motion and muscle testing devices. We focus on evaluation & rehabilitation applications in ph more...
Flexicare Medical Ltd. | Address: Cynon Valley Business Park, Moutain Ash, Mid Glamorgan CF45 4ER, United Kingdom 
www.flexicare.com | Send Inquiry | Phone: +44-(0)-1443-474647
FDA Registration: 8021995
Products: Oxygen Masks (FDA Code: BYG), Urine Collection Leg Bags (FDA Code: FAQ), Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ), Reservoir Bag (FDA Code: BTC), Nasopharyngeal Airways (FDA Code: BTQ), Urine Leg Bags (FDA Code: FAQ), ...
Flexicare Medical Ltd. manufactures and supplies medical devices to the healthcare industry & medical organizations. We focus on oxygen therapy, aerosol therapy, breathing systems, breathing filters & more...
www.flexicare.com | Send Inquiry | Phone: +44-(0)-1443-474647
FDA Registration: 8021995
Products: Oxygen Masks (FDA Code: BYG), Urine Collection Leg Bags (FDA Code: FAQ), Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ), Reservoir Bag (FDA Code: BTC), Nasopharyngeal Airways (FDA Code: BTQ), Urine Leg Bags (FDA Code: FAQ), ...
Flexicare Medical Ltd. manufactures and supplies medical devices to the healthcare industry & medical organizations. We focus on oxygen therapy, aerosol therapy, breathing systems, breathing filters & more...
Niko Surgical Ltd. | Address: Stroudwater Bus. Park, Unit 3 Brunel Way, Stroudwater Business Park, Stonehouse GL10 3SX, United Kingdom
Phone: 1453/827-696
Annual Revenues: USD 5-10 Million Employee Count: ~160
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Surgical Marking Pens (FDA Code: HRP), Suction Tubes, Ferguson-Frazier Suction Tubes, Urine Collection Leg Bags (FDA Code: FAQ), ...
Niko Surgical Ltd. deals with electrodes, fixations, and orthopedics. more...
Phone: 1453/827-696
Annual Revenues: USD 5-10 Million Employee Count: ~160
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Surgical Marking Pens (FDA Code: HRP), Suction Tubes, Ferguson-Frazier Suction Tubes, Urine Collection Leg Bags (FDA Code: FAQ), ...
Niko Surgical Ltd. deals with electrodes, fixations, and orthopedics. more...
Dachung Plastic Co Ltd | Address: No 44 Te-Xing 6th Road, Lung-Te Industrial Park, Dong-Shan 269, Taiwan 
Phone: +886-(3)-9902299
FDA Registration: 3007421188
Products: Oxygen Masks (FDA Code: BYG), Anesthetic Gas Mask (FDA Code: BSJ), Breathing Circuit Bacterial Filter (FDA Code: CAH), Breathing Mouthpiece (FDA Code: BYP), Heat and Moisture Condenser (FDA Code: BYD), Non-Rebreathing Oxygen Mask (FDA Code: KGB), ...
Dachung Plastic Co Ltd focuses on heat and moisture condensers, non-rebreathing oxygen masks and oxygen masks. more...
Phone: +886-(3)-9902299
FDA Registration: 3007421188
Products: Oxygen Masks (FDA Code: BYG), Anesthetic Gas Mask (FDA Code: BSJ), Breathing Circuit Bacterial Filter (FDA Code: CAH), Breathing Mouthpiece (FDA Code: BYP), Heat and Moisture Condenser (FDA Code: BYD), Non-Rebreathing Oxygen Mask (FDA Code: KGB), ...
Dachung Plastic Co Ltd focuses on heat and moisture condensers, non-rebreathing oxygen masks and oxygen masks. more...
Foremount Enterprise Co., Ltd. | Address: No. 17, Alley 15, Lane 5, Shenan Street, Shengang Hsiang 42944, Taiwan
www.foremount.com | Send Inquiry | Phone: +886-(4)-2561-8788
FDA Registration: 9615826 Year Established: 1996
Products: Oxygen Masks (FDA Code: BYG), Mouth Gags (FDA Code: KBN), Extension Airway Connector (FDA Code: BZA), Anesthetic Gas Mask (FDA Code: BSJ), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Breathing Mouthpiece (FDA Code: BYP), ...
Foremount Enterprise Co., Ltd. specializes in the development and manufacture of medical products. We develop and implement proactive solutions for complex medical projects in diverse manufacturing, i more...
www.foremount.com | Send Inquiry | Phone: +886-(4)-2561-8788
FDA Registration: 9615826 Year Established: 1996
Products: Oxygen Masks (FDA Code: BYG), Mouth Gags (FDA Code: KBN), Extension Airway Connector (FDA Code: BZA), Anesthetic Gas Mask (FDA Code: BSJ), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Breathing Mouthpiece (FDA Code: BYP), ...
Foremount Enterprise Co., Ltd. specializes in the development and manufacture of medical products. We develop and implement proactive solutions for complex medical projects in diverse manufacturing, i more...
Pacific Hospital Supply Co. Ltd. | Address: 4 F., No. 160, Daye Road, Beitou District, Taipei 112, Taiwan
www.pahsco.com.tw | Send Inquiry | Phone: +886-(2)-28955050
FDA Registration: 8044099
Products: Vacuum Regulator (FDA Code: KDP), Nasopharyngeal Airways (FDA Code: BTQ), Pediatric Urine Collector (FDA Code: KNX), Non Dental Irrigating Syringe (FDA Code: KYZ), Urine Collector and Accessories (FDA Code: KNX), Endometrial Suction Curette and Accessories (FDA Code: HHK), ...
Pacific Hospital Supply Co. Ltd. manufactures and processes medical gas piping systems & equipments. Our products include oxygen generating system, urine bag, wound drainage system, suction device, tu more...
www.pahsco.com.tw | Send Inquiry | Phone: +886-(2)-28955050
FDA Registration: 8044099
Products: Vacuum Regulator (FDA Code: KDP), Nasopharyngeal Airways (FDA Code: BTQ), Pediatric Urine Collector (FDA Code: KNX), Non Dental Irrigating Syringe (FDA Code: KYZ), Urine Collector and Accessories (FDA Code: KNX), Endometrial Suction Curette and Accessories (FDA Code: HHK), ...
Pacific Hospital Supply Co. Ltd. manufactures and processes medical gas piping systems & equipments. Our products include oxygen generating system, urine bag, wound drainage system, suction device, tu more...
Chain Wave Co., Ltd. | Address: 1 F., 174 Hwa Lin St., Taipei 111, Taiwan
www.chainwave.com.tw | Phone: +886-(2)-28803220, 2882 5105
Quality: ISO 9002, CE Mark Certified
Products: Oxygen Masks (FDA Code: BYG), Urine Collection Leg Bags (FDA Code: FAQ), Fistula Needle (FDA Code: FIE), Surgical Drapes & Packs (FDA Code: KKX), Infusion Catheter (FDA Code: JCY), Surgical Drapes (FDA Code: KKX), ...
Chain Wave Co.,Ltd. provides oxygen concentrators and masks. We provide jet nebulizer, disposable ambu set, air cushion masks, jet nebulizer masks, disposable oxygen mask, ER case, silicone masks, dis more...
www.chainwave.com.tw | Phone: +886-(2)-28803220, 2882 5105
Quality: ISO 9002, CE Mark Certified
Products: Oxygen Masks (FDA Code: BYG), Urine Collection Leg Bags (FDA Code: FAQ), Fistula Needle (FDA Code: FIE), Surgical Drapes & Packs (FDA Code: KKX), Infusion Catheter (FDA Code: JCY), Surgical Drapes (FDA Code: KKX), ...
Chain Wave Co.,Ltd. provides oxygen concentrators and masks. We provide jet nebulizer, disposable ambu set, air cushion masks, jet nebulizer masks, disposable oxygen mask, ER case, silicone masks, dis more...
Kc Limited | Address: 5d-08, No. 5, Sec. 5, Shin-Yi Road, Taipei 11011, Taiwan
Phone: +886-(2)-27580853
Products: Forceps (FDA Code: HTD), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Oval Eye Pads (FDA Code: HMP), Hydrophilic Wound Dressings (FDA Code: NAC), Ophthalmic Eye Pad (FDA Code: HMP), ...
Kc Limited offers a wide range of medical related products. Our products include adhesive bandages, blood collection lancets, breathing mouthpieces, disabled/handicapped hygiene adaptors, disposable h more...
Phone: +886-(2)-27580853
Products: Forceps (FDA Code: HTD), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Oval Eye Pads (FDA Code: HMP), Hydrophilic Wound Dressings (FDA Code: NAC), Ophthalmic Eye Pad (FDA Code: HMP), ...
Kc Limited offers a wide range of medical related products. Our products include adhesive bandages, blood collection lancets, breathing mouthpieces, disabled/handicapped hygiene adaptors, disposable h more...
En-Hwa Industrial Company Limited. | Address: No.32, Alley 6, Lane 137, Sec.5, Ming-Sheng East Rd., Taipei 10573, Taiwan
www.en-hwa.com.tw | Send Inquiry | Phone: +886-(2)-27602873
FDA Registration: 3007728091
Products: Medical Accessories, Blades/Handles, Biomedical Spare Parts, Breathing Mouthpiece (FDA Code: BYP), ...
En-Hwa Industrial Company Limited. specializes in the manufacture of medical spare parts and accessories. more...
www.en-hwa.com.tw | Send Inquiry | Phone: +886-(2)-27602873
FDA Registration: 3007728091
Products: Medical Accessories, Blades/Handles, Biomedical Spare Parts, Breathing Mouthpiece (FDA Code: BYP), ...
En-Hwa Industrial Company Limited. specializes in the manufacture of medical spare parts and accessories. more...
Tricare Medical Co., Ltd. | Address: 11f Dynasty Building, 155, Sec. 1, Keelung Road, Taipei 110, Taiwan
Phone: +886-(2)-27667588
FDA Registration: 3005597721
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Tricare Medical Co., Ltd. deals with medical devices and surgical instruments. We provide arm slings, forceps, ear speculums, injection cannulas, mechanical walker and disposable medical beds. We offe more...
Phone: +886-(2)-27667588
FDA Registration: 3005597721
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Tricare Medical Co., Ltd. deals with medical devices and surgical instruments. We provide arm slings, forceps, ear speculums, injection cannulas, mechanical walker and disposable medical beds. We offe more...
Vadi Medical Technology Co., Ltd. | Address: 7f-1, No. 492, Sec. 1, Wan Sou Rd., Kuei Shan Hsiang, Taoyuan Hsien 33350, Taiwan
www.vadimedical.com.tw | Send Inquiry | Phone: +886-(2)-8209-2833
FDA Registration: 9616445 Quality: ISO 9001 & 13485, CE 0434, UL Certified
Products: Oxygen Masks (FDA Code: BYG), Reservoir Bag (FDA Code: BTC), Anesthetic Gas Mask (FDA Code: BSJ), Breathing Mouthpiece (FDA Code: BYP), Gas Mask Head Strap (FDA Code: BTK), Manual Emergency Ventilator/Resuscitator (FDA Code: BTM), ...
Vadi Medical Technology Co., Ltd. specializes in the research, development and production of medical devices & consumables, which are utilized in the domains of respiratory, emergency & critical care. more...
www.vadimedical.com.tw | Send Inquiry | Phone: +886-(2)-8209-2833
FDA Registration: 9616445 Quality: ISO 9001 & 13485, CE 0434, UL Certified
Products: Oxygen Masks (FDA Code: BYG), Reservoir Bag (FDA Code: BTC), Anesthetic Gas Mask (FDA Code: BSJ), Breathing Mouthpiece (FDA Code: BYP), Gas Mask Head Strap (FDA Code: BTK), Manual Emergency Ventilator/Resuscitator (FDA Code: BTM), ...
Vadi Medical Technology Co., Ltd. specializes in the research, development and production of medical devices & consumables, which are utilized in the domains of respiratory, emergency & critical care. more...
Asia Connection Co., Ltd. | Address: 8F-4, No.16, Jian Ba Road, Chung Ho City, Taipei County 235, Taiwan
medical.asiaconnection.com.tw | Send Inquiry | Phone: +886-(2)-82265221
FDA Registration: 3006157842 Quality: ISO 9001 Certified
Products: Oxygen Masks (FDA Code: BYG), Blood pressure Cuffs (FDA Code: DXQ), Arm Slings (FDA Code: ILI), Anesthetic Gas Mask (FDA Code: BSJ), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Breathing Mouthpiece (FDA Code: BYP), ...
Asia Connection Co.,Ltd. is an US supplier of medical and home healthcare products located in Asia since 1993. We have an extensive range of medical products like face masks, protective spectacles and more...
medical.asiaconnection.com.tw | Send Inquiry | Phone: +886-(2)-82265221
FDA Registration: 3006157842 Quality: ISO 9001 Certified
Products: Oxygen Masks (FDA Code: BYG), Blood pressure Cuffs (FDA Code: DXQ), Arm Slings (FDA Code: ILI), Anesthetic Gas Mask (FDA Code: BSJ), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Breathing Mouthpiece (FDA Code: BYP), ...
Asia Connection Co.,Ltd. is an US supplier of medical and home healthcare products located in Asia since 1993. We have an extensive range of medical products like face masks, protective spectacles and more...
Intersurgical Uab | Address: 60/28-1, Arnioniu, Pabrade LT-4710, Lithuania
FDA Registration: 3001313714
Products: Oxygen Masks (FDA Code: BYG), Direct Patient Interface Respiratory Gas Humidifier (FDA Code: BTT), Extension Airway Connector (FDA Code: BZA), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Breathing Circuit Bacterial Filter (FDA Code: CAH), Breathing Mouthpiece (FDA Code: BYP), ...
Intersurgical Uab provides oxygen masks, extension airway connectors and direct patient interface nebulizers. more...
FDA Registration: 3001313714
Products: Oxygen Masks (FDA Code: BYG), Direct Patient Interface Respiratory Gas Humidifier (FDA Code: BTT), Extension Airway Connector (FDA Code: BZA), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Breathing Circuit Bacterial Filter (FDA Code: CAH), Breathing Mouthpiece (FDA Code: BYP), ...
Intersurgical Uab provides oxygen masks, extension airway connectors and direct patient interface nebulizers. more...
Kaesung Co., Ltd. | Address: 185-9 Dodang-Dong Wonmi-Gu, Bucheon-Si, KR-41 420-806, Korea, Republic Of 
www.kaesung.co.kr | Send Inquiry | Phone: +82-(32)-676-8601
FDA Registration: 3006657376
Products: Nose Clips (FDA Code: BXJ), Plastics Injection Molding, Breathing Circuit Bacterial Filter (FDA Code: CAH), Breathing Mouthpiece (FDA Code: BYP), Gas Volume Calibrator (FDA Code: BXW), Injection Molded Plastics, ...
Kaesung Co., Ltd. deals with mold and injection molding industry. Our product line includes mild making, plastic products, aluminum proto type tooling and proto molds for mobile phones. Our services i more...
www.kaesung.co.kr | Send Inquiry | Phone: +82-(32)-676-8601
FDA Registration: 3006657376
Products: Nose Clips (FDA Code: BXJ), Plastics Injection Molding, Breathing Circuit Bacterial Filter (FDA Code: CAH), Breathing Mouthpiece (FDA Code: BYP), Gas Volume Calibrator (FDA Code: BXW), Injection Molded Plastics, ...
Kaesung Co., Ltd. deals with mold and injection molding industry. Our product line includes mild making, plastic products, aluminum proto type tooling and proto molds for mobile phones. Our services i more...
Kimura Medical Instrument Co, Ltd. | Address: 17-5, Yushima 2-chome, Bunkyo-ku, Tokyo 113-0034, Japan
www.kimura-medical.co.jp | Send Inquiry | Phone: +81-(03)-3814-4481
Year Established: 1966 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001 Certified
Products: Masks & Breathing Bags, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Integrated Anesthesia Machines, Bronchial & Respiratory Aids, Spirometer & Respiratory Aids, ...
Kimura Medical Instruments Co, Ltd. deals with anesthesia machines and ventilators. We are accredited with ISO 9001:2000 and ISO13485:2003 certifications. Our anesthesia apparatus model Siesta 21 is t more...
www.kimura-medical.co.jp | Send Inquiry | Phone: +81-(03)-3814-4481
Year Established: 1966 Annual Revenues: USD 10-25 Million Employee Count: ~60 Quality: ISO 9001 Certified
Products: Masks & Breathing Bags, Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Integrated Anesthesia Machines, Bronchial & Respiratory Aids, Spirometer & Respiratory Aids, ...
Kimura Medical Instruments Co, Ltd. deals with anesthesia machines and ventilators. We are accredited with ISO 9001:2000 and ISO13485:2003 certifications. Our anesthesia apparatus model Siesta 21 is t more...
Skyfine Inc. Limited | Address: A,10/f,Blk.A,Tung Chun Ind. Bldg.,9-11, Cheung Wing Rd.,Kwai Chung, N.T., Hong Kong, HK-NA 999077, Hong Kong 
FDA Registration: 3007776657
Products: Breathing Mouthpiece (FDA Code: BYP), Alcohol Breath Trapping Device (FDA Code: DJZ), ...
Skyfine Inc. Limited specializes in providing alcohol testers and breath analyzer. more...
FDA Registration: 3007776657
Products: Breathing Mouthpiece (FDA Code: BYP), Alcohol Breath Trapping Device (FDA Code: DJZ), ...
Skyfine Inc. Limited specializes in providing alcohol testers and breath analyzer. more...
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FDA Code / Regulation: BYP / 868.5620
A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices.
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 868.9.
