Intravenous Administration Kit Suppliers
Limit companies to: Worldwide USA
Arrow International, Inc. | Address: PO Box 12888,2400 Bernville Road, Reading, Pennsylvania 19605, USA 
www.arrowintl.com | Phone: +1-(610)-655-8522
FDA Registration: 2518433 Year Established: 1975 Annual Revenues: USD 100-500 Million Employee Count: ~3250 Quality: ISO 9000, CE Certified
Products: Adapters & Connectors, Ventilator Adapter, Adapters & Connectors, Nebulizer Tee Connector, Adapters & Connectors, Trache Tee Oxygenator, Adapters & Connectors, Oxygen Supply Tubing Connector, Adapters & Connectors, Oxygen Supply Tubing Water Trap, Abdominal Diagnostic Drainage Products, ...
Arrow International, Inc. combines technology and product innovation to extend the use of catheterization for the diagnosis & treatment of critically ill patients. Our disposable critical care cathete more...
www.arrowintl.com | Phone: +1-(610)-655-8522
FDA Registration: 2518433 Year Established: 1975 Annual Revenues: USD 100-500 Million Employee Count: ~3250 Quality: ISO 9000, CE Certified
Products: Adapters & Connectors, Ventilator Adapter, Adapters & Connectors, Nebulizer Tee Connector, Adapters & Connectors, Trache Tee Oxygenator, Adapters & Connectors, Oxygen Supply Tubing Connector, Adapters & Connectors, Oxygen Supply Tubing Water Trap, Abdominal Diagnostic Drainage Products, ...
Arrow International, Inc. combines technology and product innovation to extend the use of catheterization for the diagnosis & treatment of critically ill patients. Our disposable critical care cathete 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...
Life-Tech, Inc. | Address: 4235 Greenbriar Dr., Stafford, Texas 77477-3995, USA
www.Life-Tech.com | Send Inquiry | Phone: +1-(281)-491-6600, (800)-231-9841
Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Nerve Stimulators, Constant Voltage Nerve Stimulators, Peripheral Nerve Stimulators, Electrical Nerve Stimulators, Vagal Nerve Stimulators, Iontophoresis, ...
Life-Tech, Inc. produces electronic medical devices and disposables. We are accredited with ISO 13485 certification. We offer products such as urodynamic systems and consumables, auto read & urodiary more...
www.Life-Tech.com | Send Inquiry | Phone: +1-(281)-491-6600, (800)-231-9841
Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Nerve Stimulators, Constant Voltage Nerve Stimulators, Peripheral Nerve Stimulators, Electrical Nerve Stimulators, Vagal Nerve Stimulators, Iontophoresis, ...
Life-Tech, Inc. produces electronic medical devices and disposables. We are accredited with ISO 13485 certification. We offer products such as urodynamic systems and consumables, auto read & urodiary more...
Merit Medical Systems, Inc. | Address: 1600 West Merit Parkway, South Jordan, Utah 84095, USA
www.merit.com | Send Inquiry | Phone: +1-(801)-253-1600
FDA Registration: 1721504 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1700 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Guide Catheters, Inflation Devices, Angioplasty Accessories, Pericardiocentesis Drainage Catheters, Diagnostic Guide Wires, ...
Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic more...
www.merit.com | Send Inquiry | Phone: +1-(801)-253-1600
FDA Registration: 1721504 Year Established: 1987 Annual Revenues: USD 100-500 Million Employee Count: ~1700 Quality: ISO 9001, CE Certified
Products: Cardiology Surgery Instruments, Guide Catheters, Inflation Devices, Angioplasty Accessories, Pericardiocentesis Drainage Catheters, Diagnostic Guide Wires, ...
Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic more...
Jostra Bentley, Inc. | Address: Rd. 402 N. Km 1.4, Industrial Park, Anasco 00610-1577, USA
Phone: +1-(302)-454-9959
Products: Dry and Liquid Heparin Arterial Blood Sampling Kits, Arterial Blood Sampling Kit (FDA Code: CBT), Autotransfusion Apparatus (FDA Code: CAC), Breathing Circuit Bacterial Filter (FDA Code: CAH), Arterial Line Cardiopulmonary Bypass Blood Filter (FDA Code: DTM), Cardiopulmonary Bypass Accessories (FDA Code: KRI), ...
Jostra Bentley, Inc. offers various surgical and disposable medical products. We provide arterial filters, blood infusion line, cardioplegia cooling/administration set, cardiotomy venous reservoirs, c more...
Phone: +1-(302)-454-9959
Products: Dry and Liquid Heparin Arterial Blood Sampling Kits, Arterial Blood Sampling Kit (FDA Code: CBT), Autotransfusion Apparatus (FDA Code: CAC), Breathing Circuit Bacterial Filter (FDA Code: CAH), Arterial Line Cardiopulmonary Bypass Blood Filter (FDA Code: DTM), Cardiopulmonary Bypass Accessories (FDA Code: KRI), ...
Jostra Bentley, Inc. offers various surgical and disposable medical products. We provide arterial filters, blood infusion line, cardioplegia cooling/administration set, cardiotomy venous reservoirs, c more...
RD Medical Mfg. Inc. | Address: PO Box 899 Culebra, Puerto Rico 00775, USA
www.rdmedical.com | Send Inquiry | Phone: +1-(787)-742-3800
Products: Knot Pusher, Laceration Trays, Dressing Change Tray, Debridement Tray Kit, Incision and Drainage Kit, Intravenous Administration Kit (FDA Code: FPA), ...
RD Medical Mfg. Inc. designs and manufactures medical devices. Our products are IV administration sets, needleless IV administration sets, custom IV sets and kits & procedure trays. We have the capabi more...
www.rdmedical.com | Send Inquiry | Phone: +1-(787)-742-3800
Products: Knot Pusher, Laceration Trays, Dressing Change Tray, Debridement Tray Kit, Incision and Drainage Kit, Intravenous Administration Kit (FDA Code: FPA), ...
RD Medical Mfg. Inc. designs and manufactures medical devices. Our products are IV administration sets, needleless IV administration sets, custom IV sets and kits & procedure trays. We have the capabi more...
B. Braun Of Puerto Rico, Inc. | Address: 215.7 Insular Rd., Sabana Grande 00637, USA
Phone: +1-(610)-691-5400
Products: Non-Electromagnetic Radiation Blood Warmer (FDA Code: BSB), Venous Blood-Pressure Manometer (FDA Code: KRK), Blood Transfer Unit (FDA Code: KSB), Infusion Line Filter (FDA Code: FPB), Intravenous Administration Kit (FDA Code: FPA), I.V. Container (FDA Code: KPE), ...
B. Braun Of Puerto Rico, Inc. serves the healthcare and medical instrument industries. more...
Phone: +1-(610)-691-5400
Products: Non-Electromagnetic Radiation Blood Warmer (FDA Code: BSB), Venous Blood-Pressure Manometer (FDA Code: KRK), Blood Transfer Unit (FDA Code: KSB), Infusion Line Filter (FDA Code: FPB), Intravenous Administration Kit (FDA Code: FPA), I.V. Container (FDA Code: KPE), ...
B. Braun Of Puerto Rico, Inc. serves the healthcare and medical instrument industries. more...
Atrion Medical Products, Inc. | Address: 1426 Curt Francis Rd., Arab, Alabama 35016, USA
www.atrionmedical.com | Send Inquiry | Phone: +1-(256)-586-1580, 800-343-9334
FDA Registration: 1043729 Year Established: 1968 Annual Revenues: USD 50-100 Million Employee Count: ~160 Quality: ISO 13485:2003, ISO 9001:2000, CE Certified
Products: Balloon Catheters, General Biomedical Devices, Inflation Devices, Medical Devices, Infusion Stand (FDA Code: FOX), Needle Counter, ...
Atrion Medical Products, Inc., a division of Atrion Corporation specializes in medical devices. Our product lines provide solutions for a variety of medical markets such as cardiovascular, orthopedic, more...
www.atrionmedical.com | Send Inquiry | Phone: +1-(256)-586-1580, 800-343-9334
FDA Registration: 1043729 Year Established: 1968 Annual Revenues: USD 50-100 Million Employee Count: ~160 Quality: ISO 13485:2003, ISO 9001:2000, CE Certified
Products: Balloon Catheters, General Biomedical Devices, Inflation Devices, Medical Devices, Infusion Stand (FDA Code: FOX), Needle Counter, ...
Atrion Medical Products, Inc., a division of Atrion Corporation specializes in medical devices. Our product lines provide solutions for a variety of medical markets such as cardiovascular, orthopedic, more...
Universal Medical Technologies, Inc. | Address: 15720 N. Greenway Hayden Loop, Suite 8, Scottsdale, Arizona 85260, USA
www.umtinc.com | Phone: +1-(623)-670-7614
Products: Dual-Channel Volumetric Infusion Pump, Ambulatory Infusion Pumps, Constant-flow Infusion Pump, Anesthesia Infusion Pump Tubing, Anesthetic Infusion Pump (FDA Code: FRN), Adult-Pediatric Volumetric Infusion Pumps, ...
Universal Medical Technologies, Inc. develops products that deliver intravenous solutions in an easy to use manner. Homecare staff and their patients receiving antibiotics, benefit largely from our Eu more...
www.umtinc.com | Phone: +1-(623)-670-7614
Products: Dual-Channel Volumetric Infusion Pump, Ambulatory Infusion Pumps, Constant-flow Infusion Pump, Anesthesia Infusion Pump Tubing, Anesthetic Infusion Pump (FDA Code: FRN), Adult-Pediatric Volumetric Infusion Pumps, ...
Universal Medical Technologies, Inc. develops products that deliver intravenous solutions in an easy to use manner. Homecare staff and their patients receiving antibiotics, benefit largely from our Eu more...
Acacia | Address: 785 Challenger St., Brea, California 92821, USA
www.acaciainc.com | Send Inquiry | Phone: +1-(714)-257-0470, 800-486-6677
Year Established: 1990 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 13485:2003, CE Certified
Products: Dispensing Systems, Infusion Systems, Anesthesia Extension Sets, Pain Management System, Needle Extension Set, Nerve Block Pumps, ...
Acacia designs, develops and manufactures a comprehensive line of specialty I.V. therapy sets, specialty line extensions & accessories for infusion therapy, pain management tools, & pharmacy I.V. admi more...
www.acaciainc.com | Send Inquiry | Phone: +1-(714)-257-0470, 800-486-6677
Year Established: 1990 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 13485:2003, CE Certified
Products: Dispensing Systems, Infusion Systems, Anesthesia Extension Sets, Pain Management System, Needle Extension Set, Nerve Block Pumps, ...
Acacia designs, develops and manufactures a comprehensive line of specialty I.V. therapy sets, specialty line extensions & accessories for infusion therapy, pain management tools, & pharmacy I.V. admi more...
CW Medical, Inc. | Address: 5595 Daniels Street, Suite E, Chino, California 91710, USA
www.cwmedical.us | Send Inquiry | Phone: +1-(909)-591-5220
Year Established: 1994 Annual Revenues: USD 1-5 Million
Products: Headrest System, Adult Tracheostomy Mask, Disposable Berman Airways, Endoscopic Electrosurgical Pencils, Disposable Nasal Oxygen Tube, Chest Roll Gel Positioners, ...
CW Medical Inc is a manufacturer and distributor of respiratory and general consumable products. Our health devices include digital dual channel TENS, mini TENS, moist heating pack, instant hand sanit more...
www.cwmedical.us | Send Inquiry | Phone: +1-(909)-591-5220
Year Established: 1994 Annual Revenues: USD 1-5 Million
Products: Headrest System, Adult Tracheostomy Mask, Disposable Berman Airways, Endoscopic Electrosurgical Pencils, Disposable Nasal Oxygen Tube, Chest Roll Gel Positioners, ...
CW Medical Inc is a manufacturer and distributor of respiratory and general consumable products. Our health devices include digital dual channel TENS, mini TENS, moist heating pack, instant hand sanit more...
Emed Technologies Corporation | Address: 1264 Hawks Flight Court, Suite 200, El Dorado Hills, California 95762, USA
emedicaldevices.com | Send Inquiry | Phone: +1-(888)-550-6500
FDA Registration: 2523167
Products: Infusion Therapy Kits, Fluid Delivery Tubing (FDA Code: FPK), Infusion Line Filter (FDA Code: FPB), Intravenous Administration Kit (FDA Code: FPA), Single Lumen Hypodermic Needle (FDA Code: FMI), Non-Implantable Electrical Stimulator (FDA Code: KPI), ...
Emed Technologies Corporation is a designer and manufacturer of medical devices. Our infusion(IV) pump is ideal for ambulatory and hospital use, and offers enhanced simplicity for various therapies in more...
emedicaldevices.com | Send Inquiry | Phone: +1-(888)-550-6500
FDA Registration: 2523167
Products: Infusion Therapy Kits, Fluid Delivery Tubing (FDA Code: FPK), Infusion Line Filter (FDA Code: FPB), Intravenous Administration Kit (FDA Code: FPA), Single Lumen Hypodermic Needle (FDA Code: FMI), Non-Implantable Electrical Stimulator (FDA Code: KPI), ...
Emed Technologies Corporation is a designer and manufacturer of medical devices. Our infusion(IV) pump is ideal for ambulatory and hospital use, and offers enhanced simplicity for various therapies in more...
Evans Medical Inc. | Address: 1020, Suncast lane, Suite 106, El Dorado Hills, California 95762, USA
Phone: +1-(916)-932-0071
Products: Intravenous Administration Kit (FDA Code: FPA), ...
Evans Medical Inc. offers intravenous administration kits. more...
Phone: +1-(916)-932-0071
Products: Intravenous Administration Kit (FDA Code: FPA), ...
Evans Medical Inc. offers intravenous administration kits. more...
CP Medical, Inc. | Address: 21622 Surveyor Circle, Huntington Beach, California 92646, USA
www.cpmednet.com | Send Inquiry | Phone: +1-(714)-969-6818, 800-669-6973
FDA Registration: 3012164473 Year Established: 1981 Annual Revenues: USD 1-5 Million
Products: Clamps, Blood Tubing Sets, Broviac catheters, Back Supports, Blood Administration Sets, Bedpan (FDA Code: FOB), ...
CP Medical, Inc. specializes in offering hemodialysis solutions, powders and ancillary products to dialysis in the healthcare industry. We also offer a variety of modesty garments for visual imaging a more...
www.cpmednet.com | Send Inquiry | Phone: +1-(714)-969-6818, 800-669-6973
FDA Registration: 3012164473 Year Established: 1981 Annual Revenues: USD 1-5 Million
Products: Clamps, Blood Tubing Sets, Broviac catheters, Back Supports, Blood Administration Sets, Bedpan (FDA Code: FOB), ...
CP Medical, Inc. specializes in offering hemodialysis solutions, powders and ancillary products to dialysis in the healthcare industry. We also offer a variety of modesty garments for visual imaging a more...
I-Flow Corporation | Address: 20202 Windrow Dr., Lake Forest, California 92630, USA
www.I-flowcorp.com | Send Inquiry | Phone: +1-(949)-206-2700, 800-448-3569
FDA Registration: 2026095 Year Established: 1985 Annual Revenues: USD 25-50 Million Employee Count: ~70 Quality: ISO 9000, ISO 9001, CE Certified
Products: Adhesive Bandages (FDA Code: KGX), Ambulatory Infusion Pumps, Anesthetic Infusion Pump (FDA Code: FRN), Anesthetic Conduction Catheter (FDA Code: BSO), Elastomeric Infusion Pump (FDA Code: MEB), Drug Wound Dressing (FDA Code: FRO), ...
I-Flow Corporation designs, develops and markets technically advanced drug delivery systems that redefine the standard of care by providing life enhancing, cost effective solutions for pain relief. We more...
www.I-flowcorp.com | Send Inquiry | Phone: +1-(949)-206-2700, 800-448-3569
FDA Registration: 2026095 Year Established: 1985 Annual Revenues: USD 25-50 Million Employee Count: ~70 Quality: ISO 9000, ISO 9001, CE Certified
Products: Adhesive Bandages (FDA Code: KGX), Ambulatory Infusion Pumps, Anesthetic Infusion Pump (FDA Code: FRN), Anesthetic Conduction Catheter (FDA Code: BSO), Elastomeric Infusion Pump (FDA Code: MEB), Drug Wound Dressing (FDA Code: FRO), ...
I-Flow Corporation designs, develops and markets technically advanced drug delivery systems that redefine the standard of care by providing life enhancing, cost effective solutions for pain relief. We more...
US Safety Syringes Co | Address: 6601 Spring Park Avenue, No. 5, Los Angeles, California 90056, USA
Phone: +1-(757)-2240177
Products: Antistick Syringe (FDA Code: MEG), Intravenous Administration Kit (FDA Code: FPA), Single Lumen Hypodermic Needle (FDA Code: FMI), ...
US Safety Syringes Co. supplies syringes and various medical accessories. We also provide anti-stick syringes, intravenous administration kits, and single lumen hypodermic needles. more...
Phone: +1-(757)-2240177
Products: Antistick Syringe (FDA Code: MEG), Intravenous Administration Kit (FDA Code: FPA), Single Lumen Hypodermic Needle (FDA Code: FMI), ...
US Safety Syringes Co. supplies syringes and various medical accessories. We also provide anti-stick syringes, intravenous administration kits, and single lumen hypodermic needles. more...
LifeScan, Inc. | Address: 1000 Gibraltar Drive, Milpitas, California 95035, USA
www.lifescan.com | Send Inquiry | Phone: +1-(408)-263-9789
FDA Registration: 3009698388 Annual Revenues: < USD 1 Million Employee Count: ~1400
Products: Anesthesia Equipment, Controls, Diabetic Monitoring, Lancet Devices, General Diagnostic Supplies, General Medical Supplies, ...
LifeScan, Inc. provides blood glucose monitoring systems for home & hospital use. We are specialized in blood glucose monitoring with the introduction of OneTouch® Technology, which eliminates wip more...
www.lifescan.com | Send Inquiry | Phone: +1-(408)-263-9789
FDA Registration: 3009698388 Annual Revenues: < USD 1 Million Employee Count: ~1400
Products: Anesthesia Equipment, Controls, Diabetic Monitoring, Lancet Devices, General Diagnostic Supplies, General Medical Supplies, ...
LifeScan, Inc. provides blood glucose monitoring systems for home & hospital use. We are specialized in blood glucose monitoring with the introduction of OneTouch® Technology, which eliminates wip more...
Pfm Medical, Inc | Address: 2605 Temple Heights Drive, Suite A, Oceanside, California 92056, USA
www.pfmmedical.com | Send Inquiry | Phone: +1-(760)-7588749
FDA Registration: 3013666218 Quality: ISO 13485 Certified
Products: Embolectomy Catheters (FDA Code: DXE), AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), Operating Room Scrub Brush (FDA Code: GEC), Implanted Subcutaneous Intravascular Port & Catheter (FDA Code: LJT), Intravenous Administration Kit (FDA Code: FPA), Therapeutic Intravascular Catheter (FDA Code: LJS), ...
Pfm Medical, Inc specializes in products such as EZ Huber®, pfm PICC Catheters, and interventional cardiology. The EZ huber isolates the caregiver from harmful patient fluids and oncology drug spl more...
www.pfmmedical.com | Send Inquiry | Phone: +1-(760)-7588749
FDA Registration: 3013666218 Quality: ISO 13485 Certified
Products: Embolectomy Catheters (FDA Code: DXE), AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), Operating Room Scrub Brush (FDA Code: GEC), Implanted Subcutaneous Intravascular Port & Catheter (FDA Code: LJT), Intravenous Administration Kit (FDA Code: FPA), Therapeutic Intravascular Catheter (FDA Code: LJS), ...
Pfm Medical, Inc specializes in products such as EZ Huber®, pfm PICC Catheters, and interventional cardiology. The EZ huber isolates the caregiver from harmful patient fluids and oncology drug spl more...
Medegen Medical Manufacturing Services | Address: 930 Wanamaker Ave., Ontario, California 91761, USA
www.medegen.com | Send Inquiry | Phone: +1-(800)-520-7999
Quality: ISO 13485 Certified
Products: Contract Manufacturers, Product Design & Development, Contract Manufacturing, Custom Molding, Disposable Product Contract Manufacturing, Medical Device Contract Manufacturing, ...
Medegen Medical Manufacturing Services is engaged in the production of IV components. Our KippMed® components include NAC™ and NACPlus™ needleless access devices, male luer lock fittin more...
www.medegen.com | Send Inquiry | Phone: +1-(800)-520-7999
Quality: ISO 13485 Certified
Products: Contract Manufacturers, Product Design & Development, Contract Manufacturing, Custom Molding, Disposable Product Contract Manufacturing, Medical Device Contract Manufacturing, ...
Medegen Medical Manufacturing Services is engaged in the production of IV components. Our KippMed® components include NAC™ and NACPlus™ needleless access devices, male luer lock fittin 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...
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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.
