Intravenous Administration Kit Suppliers
Limit companies to: Worldwide USA
Zyno Medical LLC. | Address: 395 Totten Pond Road, Suite 201, Waltham, Massachusetts 02451, USA 
www.zynomed.com | Send Inquiry | Phone: +1-(781)-895-1988
FDA Registration: 3006575795
Products: IV Sets, Anesthetic Infusion Pump (FDA Code: FRN), Peristaltic Infusion Pump (FDA Code: FRN), Enteral Infusion Pump (FDA Code: LZH), Intravenous Administration Kit (FDA Code: FPA), Pole Mounted Volumetric Infusion Pumps, ...
Zyno Medical LLC. is a manufacturer of infusion pumps. Our Z-800 infusion pump is an intuitive setup for primary and secondary infusions. Our pump has a large display, which provides all the informati more...
www.zynomed.com | Send Inquiry | Phone: +1-(781)-895-1988
FDA Registration: 3006575795
Products: IV Sets, Anesthetic Infusion Pump (FDA Code: FRN), Peristaltic Infusion Pump (FDA Code: FRN), Enteral Infusion Pump (FDA Code: LZH), Intravenous Administration Kit (FDA Code: FPA), Pole Mounted Volumetric Infusion Pumps, ...
Zyno Medical LLC. is a manufacturer of infusion pumps. Our Z-800 infusion pump is an intuitive setup for primary and secondary infusions. Our pump has a large display, which provides all the informati more...
Smiths Medical ASD, Inc | Address: 9 Riverside Road, Weston, Massachusetts 02493, USA
Send Inquiry | Phone: +1-(603)-352-3812
FDA Registration: 1824231 Year Established: 1978 Annual Revenues: USD 25-50 Million Employee Count: ~280 Quality: ISO 9001, CE Certified
Products: Anesthesia, Anesthetics, Anesthetics, Anesthesia Ring, Angled Thoracic Catheters, Amniocentesis Needles, ...
Smiths Medical ASD, Inc supplies devices that are used during critical & intensive care, surgery, post-operative care during recovery & in a series of high-end home infusion therapies. We focus on dev more...
Send Inquiry | Phone: +1-(603)-352-3812
FDA Registration: 1824231 Year Established: 1978 Annual Revenues: USD 25-50 Million Employee Count: ~280 Quality: ISO 9001, CE Certified
Products: Anesthesia, Anesthetics, Anesthetics, Anesthesia Ring, Angled Thoracic Catheters, Amniocentesis Needles, ...
Smiths Medical ASD, Inc supplies devices that are used during critical & intensive care, surgery, post-operative care during recovery & in a series of high-end home infusion therapies. We focus on dev more...
Accellent Inc. | Address: 100 Fordham Road, Wilmington, Massachusetts 01010, USA
www.accellent.com | Send Inquiry | Phone: +1-(978)-570-6900/866-899-1392
FDA Registration: 1218882 Year Established: 2000 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9003 Certified
Products: Active Closure Devices, Arthroscopy Instruments, Biopsy Forceps, Balloon Catheters, Beating Heart Surgery System, Anastomosis Device Sizer, ...
Accellent Inc specializes in providing chain solutions to cardiology, drug delivery, endoscopy, neurology, orthopaedic and general medical fields. We design, develop, manufacture and assemble implants more...
www.accellent.com | Send Inquiry | Phone: +1-(978)-570-6900/866-899-1392
FDA Registration: 1218882 Year Established: 2000 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9003 Certified
Products: Active Closure Devices, Arthroscopy Instruments, Biopsy Forceps, Balloon Catheters, Beating Heart Surgery System, Anastomosis Device Sizer, ...
Accellent Inc specializes in providing chain solutions to cardiology, drug delivery, endoscopy, neurology, orthopaedic and general medical fields. We design, develop, manufacture and assemble implants more...
Topspins, Inc. | Address: 403 Riverview Dr., Ann Arbor, Michigan 48104, USA
www.topspins.com | Send Inquiry | Phone: +1-(734)-623-6400
Products: Pneumatic Tourniquet (FDA Code: KCY), Needleless I.V. Administration Sets, I.V. Start Kits (FDA Code: LRS), Intravenous Administration Kit (FDA Code: FPA), Hand Injection Tubing Systems, ...
Topspins, Inc. focuses on magnetic resonance angiography systems. Our Smart set 001.4 is a tubing system that is used for hand injection of contrast and flush. We provide gadolinium infusion set that more...
www.topspins.com | Send Inquiry | Phone: +1-(734)-623-6400
Products: Pneumatic Tourniquet (FDA Code: KCY), Needleless I.V. Administration Sets, I.V. Start Kits (FDA Code: LRS), Intravenous Administration Kit (FDA Code: FPA), Hand Injection Tubing Systems, ...
Topspins, Inc. focuses on magnetic resonance angiography systems. Our Smart set 001.4 is a tubing system that is used for hand injection of contrast and flush. We provide gadolinium infusion set that more...
Optovent Holdings, Llc Dba Mediquest Life Science, Llc | Address: 42030 Koppernick Rd., Suite 309, Canton, Michigan 48187, USA
Phone: +1-(757)-224-0177
Products: Intravenous Administration Kit (FDA Code: FPA), ...
Optovent Holdings, Llc Dba Mediquest Life Science, Llc specializes in the production of intravenous administration kits. more...
Phone: +1-(757)-224-0177
Products: Intravenous Administration Kit (FDA Code: FPA), ...
Optovent Holdings, Llc Dba Mediquest Life Science, Llc specializes in the production of intravenous administration kits. more...
Mobile I.V. Systems | Address: 4190 Sunnyside Drive, Holland, Michigan 49424, USA
www.mobileivsystems.com | Send Inquiry | Phone: +1-(619)-717-5769
Products: Intravenous Administration Kit (FDA Code: FPA), Pressure Infusor for I.V. Bags (FDA Code: KZD), IV Systems, ...
Mobile I.V. Systems specializes in offering self powered I.V systems. Our mobile I.V systems include patent-pending inflatible cuff and twist-to-activate CO2 cartridge which provides constant, even pr more...
www.mobileivsystems.com | Send Inquiry | Phone: +1-(619)-717-5769
Products: Intravenous Administration Kit (FDA Code: FPA), Pressure Infusor for I.V. Bags (FDA Code: KZD), IV Systems, ...
Mobile I.V. Systems specializes in offering self powered I.V systems. Our mobile I.V systems include patent-pending inflatible cuff and twist-to-activate CO2 cartridge which provides constant, even pr more...
Centurion Medical Products | Address: 301 Catrell Drive, Howell, Michigan 48843, USA
www.tshsc.com | Send Inquiry | Phone: +1-(516)-546-5400, 800-248-4058
FDA Registration: 1824619 Year Established: 1961 Employee Count: ~720 Quality: ISO 9000, ISO 9001, CE Certified
Products: Scissors, Iris Scissors, Gauze Dressings, Hemostats, Island Dressings, Labels & Signs, ...
Centurion Medical Products provides a variety of custom procedure kits, trays and specialty products to hospitals, health care facilities, non acute alternate site & home care providers. All our facil more...
www.tshsc.com | Send Inquiry | Phone: +1-(516)-546-5400, 800-248-4058
FDA Registration: 1824619 Year Established: 1961 Employee Count: ~720 Quality: ISO 9000, ISO 9001, CE Certified
Products: Scissors, Iris Scissors, Gauze Dressings, Hemostats, Island Dressings, Labels & Signs, ...
Centurion Medical Products provides a variety of custom procedure kits, trays and specialty products to hospitals, health care facilities, non acute alternate site & home care providers. All our facil more...
Arkray Factory USA, Inc. | Address: 5182 West 76th St., Minneapolis, Minnesota 55439, USA
Phone: +1-(952)-646-3168
FDA Registration: 1832816
Products: Blood Lancets, Blood Lancet Needle (Pen Type), Blood Lancet Needle (Blade Type), Stainless Steel Blood Lancets, Plastic Blood Lancets, Blood Collection Lancet (FDA Code: FMK), ...
Arkray Factory USA, Inc. is engaged in the production of medical and surgical equipments. Our product line includes urine test strips, urine chemistry analyzers, intravascular catheters and blood gluc more...
Phone: +1-(952)-646-3168
FDA Registration: 1832816
Products: Blood Lancets, Blood Lancet Needle (Pen Type), Blood Lancet Needle (Blade Type), Stainless Steel Blood Lancets, Plastic Blood Lancets, Blood Collection Lancet (FDA Code: FMK), ...
Arkray Factory USA, Inc. is engaged in the production of medical and surgical equipments. Our product line includes urine test strips, urine chemistry analyzers, intravascular catheters and blood gluc more...
Biomedix, Inc. | Address: 4215 White Bear Parkway, St Paul, Minnesota 55110, USA
www.biomedix.com | Send Inquiry | Phone: +1-(651)-762-4010, 877-854-0012
FDA Registration: 2134492 Year Established: 1977 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Ultrasonic Transducer (FDA Code: JOP), Indirect Blood Pressure Monitor, Hydraulic Photo-Electric Plethysmograph (FDA Code: JOM), Ultrasonic Blood Flow Detector, Medical Computer and Software (FDA Code: LNX), Non-Fetal Ultrasonic Monitor (FDA Code: JAF), ...
Biomedix, Inc. focuses on early detection of vascular disease. Our PADnet+ is a reimbursable peripheral vascular disease diagnostic device that can be used by medical staff in primary & podiatric care more...
www.biomedix.com | Send Inquiry | Phone: +1-(651)-762-4010, 877-854-0012
FDA Registration: 2134492 Year Established: 1977 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Ultrasonic Transducer (FDA Code: JOP), Indirect Blood Pressure Monitor, Hydraulic Photo-Electric Plethysmograph (FDA Code: JOM), Ultrasonic Blood Flow Detector, Medical Computer and Software (FDA Code: LNX), Non-Fetal Ultrasonic Monitor (FDA Code: JAF), ...
Biomedix, Inc. focuses on early detection of vascular disease. Our PADnet+ is a reimbursable peripheral vascular disease diagnostic device that can be used by medical staff in primary & podiatric care more...
Hemerus Medical, Llc. | Address: 5000, Township Parkway, St. Paul, Minnesota 55110, USA
www.hemerus.com | Send Inquiry | Phone: +1-(651)-635-0070
Quality: ISO 13485 Certified
Products: Blood Transfusion Microfilter (FDA Code: CAK), Intravenous Administration Kit (FDA Code: FPA), ...
Hemerus Medical, Llc. designs, develops and manufactures technologies for collection, processing & storage of blood & blood products. Our Leukosep® HRC-600-C leukocyte reduction filtration system more...
www.hemerus.com | Send Inquiry | Phone: +1-(651)-635-0070
Quality: ISO 13485 Certified
Products: Blood Transfusion Microfilter (FDA Code: CAK), Intravenous Administration Kit (FDA Code: FPA), ...
Hemerus Medical, Llc. designs, develops and manufactures technologies for collection, processing & storage of blood & blood products. Our Leukosep® HRC-600-C leukocyte reduction filtration system more...
Disetronic Sterile Products | Address: 124 Heritage Avenue, Portsmouth, New Hampshire 03801-5645, USA
www.dspusa.tv | Send Inquiry | Phone: +1-(603)-427-5511, 800-280-7801
Year Established: 1985 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9002, CE Certified
Products: Contract Manufacturing, Contract Packaging, Intravenous Administration Kit (FDA Code: FPA), ...
Disetronic Sterile Products is a manufacturer of insulin pumps. We provide catheters, infusion devices and extension sets. more...
www.dspusa.tv | Send Inquiry | Phone: +1-(603)-427-5511, 800-280-7801
Year Established: 1985 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9002, CE Certified
Products: Contract Manufacturing, Contract Packaging, Intravenous Administration Kit (FDA Code: FPA), ...
Disetronic Sterile Products is a manufacturer of insulin pumps. We provide catheters, infusion devices and extension sets. more...
Multi-Med, Inc. | Address: Winchester St., P.O. Box 660, West Swanzey, New Hampshire 03469, USA
www.multimedinc.com | Send Inquiry | Phone: +1-(603)-357-8733
FDA Registration: 1221765 Annual Revenues: < USD 1 Million
Products: Feeding Tubes (FDA Code: FPD), Cardiovascular Biopsy Needle (FDA Code: DWO), Continuous Electronic Thermometer (FDA Code: FLL), Disposable Product Contract Manufacturing, Elastomeric Infusion Pump (FDA Code: MEB), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Multi-Med, Inc. is a manufacturer and packager of custom medical disposables. We specialize in the packaging of custom medical disposables such as extension and administration sets. We produce sub-Q, more...
www.multimedinc.com | Send Inquiry | Phone: +1-(603)-357-8733
FDA Registration: 1221765 Annual Revenues: < USD 1 Million
Products: Feeding Tubes (FDA Code: FPD), Cardiovascular Biopsy Needle (FDA Code: DWO), Continuous Electronic Thermometer (FDA Code: FLL), Disposable Product Contract Manufacturing, Elastomeric Infusion Pump (FDA Code: MEB), Gastrointestinal Tube and Accessories (FDA Code: KNT), ...
Multi-Med, Inc. is a manufacturer and packager of custom medical disposables. We specialize in the packaging of custom medical disposables such as extension and administration sets. We produce sub-Q, more...
Vlv Associates, Inc. | Address: 30-C Ridgedale Ave., East Hanover, New Jersey 07936, USA
www.vlvassociates.com | Send Inquiry | Phone: +1-(973)-428-2884
FDA Registration: 2245539 Year Established: 1982 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 13485:2003 Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Catheter Introducers, MULLINS, Implantable Venous Access Catheter Introducer Kits, Foley Catheter Introducer, Endomyocardial Biopsy Device (FDA Code: DWZ), ...
Vlv Associates, Inc. manufactures products for use in intravascular therapy, urology and hemodialysis. Our health care products include suction tube set, biopsy and safety needles. Our suction tube tr more...
www.vlvassociates.com | Send Inquiry | Phone: +1-(973)-428-2884
FDA Registration: 2245539 Year Established: 1982 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO 13485:2003 Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Catheter Introducers, MULLINS, Implantable Venous Access Catheter Introducer Kits, Foley Catheter Introducer, Endomyocardial Biopsy Device (FDA Code: DWZ), ...
Vlv Associates, Inc. manufactures products for use in intravascular therapy, urology and hemodialysis. Our health care products include suction tube set, biopsy and safety needles. Our suction tube tr more...
BD Diagnostics - Preanalytical Systems | Address: 1 Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com | Send Inquiry | Phone: +1-(800)-631-0174, 888-237-2762
FDA Registration: 1024879
Products: Blood Collection Sets, Adult Catheter Kit, Alcohol Swabs, Allergy Syringe, Blood Collection Systems (FDA Code: JKA), Blood Transfer Unit (FDA Code: KSB), ...
BD Diagnostics - Preanalytical Systems manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefill more...
www.bd.com | Send Inquiry | Phone: +1-(800)-631-0174, 888-237-2762
FDA Registration: 1024879
Products: Blood Collection Sets, Adult Catheter Kit, Alcohol Swabs, Allergy Syringe, Blood Collection Systems (FDA Code: JKA), Blood Transfer Unit (FDA Code: KSB), ...
BD Diagnostics - Preanalytical Systems manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefill more...
Genesis BPS | Address: No. 65 Commerce Way, Hackensack, New Jersey 07601, USA
www.genesisbps.com | Send Inquiry | Phone: +1-(201)-708-1400
FDA Registration: 2248588
Products: Blood Transfusion Sets (FDA Code: BRZ), Piston Syringe (FDA Code: FMF), Blood Bag, Blood Mixing and Weighing Device (FDA Code: KSQ), Blood Transfer Unit (FDA Code: KSB), Blood & Components Collection Container (FDA Code: KSR), ...
Genesis BPS specializes in offering Genesis™ line of products for blood collection, storage & processing and laboratory equipments. Our Genesis™ blood collection monitor electronically mon more...
www.genesisbps.com | Send Inquiry | Phone: +1-(201)-708-1400
FDA Registration: 2248588
Products: Blood Transfusion Sets (FDA Code: BRZ), Piston Syringe (FDA Code: FMF), Blood Bag, Blood Mixing and Weighing Device (FDA Code: KSQ), Blood Transfer Unit (FDA Code: KSB), Blood & Components Collection Container (FDA Code: KSR), ...
Genesis BPS specializes in offering Genesis™ line of products for blood collection, storage & processing and laboratory equipments. Our Genesis™ blood collection monitor electronically mon more...
Excelsior Medical Corporation | Address: 1933 Heck Avenue, Neptune, New Jersey 07753, USA
www.excelsiormedical.com | Phone: +1-(732)-776-7525, 800-487-4276
FDA Registration: 2027791
Products: Syringe Pumps, Anesthetic Infusion Pump (FDA Code: FRN), Flush Syringes, Heparin Flush Syringes, Dispensing Pumps, Catheter Flush Syringes, ...
Excelsior Medical Corporation is a manufacturer of pre-filled catheter flush syringes and syringe pump systems. We develop intra-luminal catheter care products that reduce infection and medication err more...
www.excelsiormedical.com | Phone: +1-(732)-776-7525, 800-487-4276
FDA Registration: 2027791
Products: Syringe Pumps, Anesthetic Infusion Pump (FDA Code: FRN), Flush Syringes, Heparin Flush Syringes, Dispensing Pumps, Catheter Flush Syringes, ...
Excelsior Medical Corporation is a manufacturer of pre-filled catheter flush syringes and syringe pump systems. We develop intra-luminal catheter care products that reduce infection and medication err more...
Vital Signs, Inc. | Address: 20 Campus Road, Totowa, New Jersey 07512, USA
www.vital-signs.com | Send Inquiry | Phone: +1-(800)-932-0760
Year Established: 1972 Annual Revenues: USD 100-500 Million Employee Count: ~1160 Quality: ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Stethoscopes, Anesthesia, Disposable Syringes, Emergency Care Supplies, Irrigation Sets & Tubing, Aspirators, ...
Vital Signs, Inc. deals with single patient use products. We focus on reducing nosocomial infections. Our face masks are soft, pliable, air-filled cushion molds that have a low-pressure seal. Our Vita more...
www.vital-signs.com | Send Inquiry | Phone: +1-(800)-932-0760
Year Established: 1972 Annual Revenues: USD 100-500 Million Employee Count: ~1160 Quality: ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Stethoscopes, Anesthesia, Disposable Syringes, Emergency Care Supplies, Irrigation Sets & Tubing, Aspirators, ...
Vital Signs, Inc. deals with single patient use products. We focus on reducing nosocomial infections. Our face masks are soft, pliable, air-filled cushion molds that have a low-pressure seal. Our Vita more...
Harmac Medical Products, Inc. | Address: 2201 Bailey Avenue, Buffalo, New York 14211, USA
www.harmac.com | Send Inquiry | Phone: +1-(716)-897-4500
FDA Registration: 1317547 Annual Revenues: USD 10-25 Million Employee Count: ~70 Quality: ISO 9001:2000, ISO 13485:2003 Certified
Products: Contract Manufacturers, Critical Care Devices, Ophthalmology Instruments, Medical Devices, Cardiology Services, Contract Packaging, ...
Harmac Medical Products, Inc. is a full-service, vertically integrated, contract medical device manufacturer. From concept to design, manufacturing and packaging, we produce high-quality, custom, sing more...
www.harmac.com | Send Inquiry | Phone: +1-(716)-897-4500
FDA Registration: 1317547 Annual Revenues: USD 10-25 Million Employee Count: ~70 Quality: ISO 9001:2000, ISO 13485:2003 Certified
Products: Contract Manufacturers, Critical Care Devices, Ophthalmology Instruments, Medical Devices, Cardiology Services, Contract Packaging, ...
Harmac Medical Products, Inc. is a full-service, vertically integrated, contract medical device manufacturer. From concept to design, manufacturing and packaging, we produce high-quality, custom, sing more...
American Australian Medical, Inc. | Address: 1083 Delaware Avenue, Buffalo, New York 14209, USA
www.americanaustralianmedical.com | Send Inquiry | Phone: +1-(716)-440 0405
FDA Registration: 2438444 Quality: IS0 9001, CE Certified
Products: Adhesive Bandages (FDA Code: KGX), Amniotome (FDA Code: HGE), Anesthetic Infusion Pump (FDA Code: FRN), Disposable Aspiration and Injection Needle (FDA Code: GAA), Elastomeric Infusion Pump (FDA Code: MEB), Fetal Vacuum Extractor (FDA Code: HDB), ...
American Australian Medical Inc. provides tools and technology for health care physicians. Our products include adhesive bandages, anesthetic, elastomeric & peristaltic infusion pumps, disposable aspi more...
www.americanaustralianmedical.com | Send Inquiry | Phone: +1-(716)-440 0405
FDA Registration: 2438444 Quality: IS0 9001, CE Certified
Products: Adhesive Bandages (FDA Code: KGX), Amniotome (FDA Code: HGE), Anesthetic Infusion Pump (FDA Code: FRN), Disposable Aspiration and Injection Needle (FDA Code: GAA), Elastomeric Infusion Pump (FDA Code: MEB), Fetal Vacuum Extractor (FDA Code: HDB), ...
American Australian Medical Inc. provides tools and technology for health care physicians. Our products include adhesive bandages, anesthetic, elastomeric & peristaltic infusion pumps, disposable aspi more...
Angiodynamics, Inc. | Address: 603 Queensbury Ave, Queensbury, New York 12804, USA
www.angiodynamics.com | Send Inquiry | Phone: +1-(518)-798-1215, 800-772-6446
FDA Registration: 1056436 Year Established: 1990 Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Angiographic Catheter, El Gamal Sones, Angiographic Catheter, El Gamal Multipurpose, Anesthetic Infusion Pump (FDA Code: FRN), Angiographic Catheter, ...
Angiodynamics, Inc. provides medical devices for radiologists, surgeons, and other physicians. We offer medical devices for the minimally invasive diagnosis and treatment of cancer and peripheral vasc more...
www.angiodynamics.com | Send Inquiry | Phone: +1-(518)-798-1215, 800-772-6446
FDA Registration: 1056436 Year Established: 1990 Annual Revenues: USD 25-50 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Angiographic Catheter, Angled Pigtail, Angiographic Catheter Amplatz Left 1.0, Angiographic Catheter, El Gamal Sones, Angiographic Catheter, El Gamal Multipurpose, Anesthetic Infusion Pump (FDA Code: FRN), Angiographic Catheter, ...
Angiodynamics, Inc. provides medical devices for radiologists, surgeons, and other physicians. We offer medical devices for the minimally invasive diagnosis and treatment of cancer and peripheral vasc more...
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FDA Code / Regulation: FPA / 880.5440
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled "Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers." Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in 880.9.
