Stopcock, I.V.Set Suppliers
Limit companies to: Worldwide USA
Interpore Cross International, Inc. | Address: 181 Technology Drive, Irvine, California 92618, USA 
www.crossmedical.com | Send Inquiry | Phone: +1-(949)-453-3200
FDA Registration: 2029012 Year Established: 1975 Annual Revenues: USD 50-100 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Synthetic Spacers, Demineralized Bone Matrix, Hydroxyapatite, Autologous Platelet Gel Preparation Systems, Human Demineralized Bone Matrix, Osteoinductive Demineralized Bone Matrix, ...
Interpore Cross International, Inc. is a public medical device company, which focuses on products for spinal surgery. Our CDO system renders key benefits for surgeons and their patients, including dia more...
www.crossmedical.com | Send Inquiry | Phone: +1-(949)-453-3200
FDA Registration: 2029012 Year Established: 1975 Annual Revenues: USD 50-100 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Synthetic Spacers, Demineralized Bone Matrix, Hydroxyapatite, Autologous Platelet Gel Preparation Systems, Human Demineralized Bone Matrix, Osteoinductive Demineralized Bone Matrix, ...
Interpore Cross International, Inc. is a public medical device company, which focuses on products for spinal surgery. Our CDO system renders key benefits for surgeons and their patients, including dia more...
Autosuture | Address: 150 Glover Avenue, Norwalk, Connecticut 06856, USA
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
www.autosuture.com | Send Inquiry | Phone: +1-(800)-722-8772
Annual Revenues: > USD 1 Billion Employee Count: ~5780 Quality: ISO 9001, ISO 9002, CE Certified
Products: Forceps (FDA Code: HTD), Retractors, Scissors, Meniscal Repair Systems, Absorbable Suture Anchors, Suture Anchors, ...
Autosuture offers a complete line of surgical products and instrumentation that surgeons utilize for laparoscopic, endoscopic & traditional open surgical procedures & lymphatic mapping. We are an ISO more...
Hospira, Inc. | Address: 275 N. Field Dr., Lake Forest, Illinois 60045, USA
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in more...
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in 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...
Cook Group Incorporated | Address: P.O. Box 489, Bloomington, Indiana 47402-0489, USA
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
www.cookgroup.com | Phone: +1-(812)-339-2235, 800-457-4500
FDA Registration: 1820334 Employee Count: ~340 Quality: ISO 9000, CE Certified
Products: Ansel Modification, Balloon Catheters, Ansel Modification ANL Curve, Areolar Connective Tissue Grafts In Pediatric, Drug Clinical Trial Service, Centimeter Sizing Catheters, ...
Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blo more...
Becton, Dickson & Co., | Address: One Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje 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...
B. Braun Medical Inc. | Address: 824 Twelfth Avenue, Bethlehem, Pennsylvania 18018-3524, USA
www.bbraunusa.com | Send Inquiry | Phone: +1-(610)-691-5400
FDA Registration: 2523676 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~600 Quality: ISO 9000, CE Certified
Products: Procedure Trays, Caps, Disposable Needles, IV Catheters & Infusion Sets, IV Sets, General Medical Supplies, ...
B. Braun Medical Inc. offers medical products. Our product categories are admixture products, dialysis products, infusion pump systems & sets, urology sets & solutions, pain control products and vascu more...
www.bbraunusa.com | Send Inquiry | Phone: +1-(610)-691-5400
FDA Registration: 2523676 Year Established: 1979 Annual Revenues: USD 10-25 Million Employee Count: ~600 Quality: ISO 9000, CE Certified
Products: Procedure Trays, Caps, Disposable Needles, IV Catheters & Infusion Sets, IV Sets, General Medical Supplies, ...
B. Braun Medical Inc. offers medical products. Our product categories are admixture products, dialysis products, infusion pump systems & sets, urology sets & solutions, pain control products and vascu 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...
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...
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...
G.L. Medical | Address: 9814 Curwood Pl., Beverly Hills, California 90210, USA
Phone: +1-(310)-2751427
Products: Stopcock, I.V.Set (FDA Code: FMG), ...
G.L. Medical offers stopcocks and I.V.sets. more...
Phone: +1-(310)-2751427
Products: Stopcock, I.V.Set (FDA Code: FMG), ...
G.L. Medical offers stopcocks and I.V.sets. more...
Surgin Surgical Instrumentation, Inc. (Surgin Inc.) | Address: 37 Shield, Irvine, California 92618, USA
www.surgin.com | Send Inquiry | Phone: +1-(714)-832-6300, 800-753-7400
FDA Registration: 2023739 Year Established: 1981 Annual Revenues: USD 1-5 Million Employee Count: ~60 Quality: ISO 9001,ISO 13485, CE Certified
Products: Implantable Staple (FDA Code: GDW), Irrigation Tubing, Non-Invasive Tubing (FDA Code: GAZ), AC-Powered Keratome (FDA Code: HNO), Spectacle Frame (FDA Code: HQZ), Dual Syringe Injectors, ...
Surgin Surgical Instrumentation, Inc. (Surgin Inc.) specializes in the design and manufacture of surgical devices. We provide surgical devices for surgical specialties including arthroscopy, ophthalmo more...
www.surgin.com | Send Inquiry | Phone: +1-(714)-832-6300, 800-753-7400
FDA Registration: 2023739 Year Established: 1981 Annual Revenues: USD 1-5 Million Employee Count: ~60 Quality: ISO 9001,ISO 13485, CE Certified
Products: Implantable Staple (FDA Code: GDW), Irrigation Tubing, Non-Invasive Tubing (FDA Code: GAZ), AC-Powered Keratome (FDA Code: HNO), Spectacle Frame (FDA Code: HQZ), Dual Syringe Injectors, ...
Surgin Surgical Instrumentation, Inc. (Surgin Inc.) specializes in the design and manufacture of surgical devices. We provide surgical devices for surgical specialties including arthroscopy, ophthalmo more...
ICU Medical, Inc | Address: 951 Calle Amanecer, San Clemente, California 92673, USA
www.icumed.com | Send Inquiry | Phone: +1-(949)-366-2183, 800-824-7890
FDA Registration: 1713468 Year Established: 1984 Employee Count: ~1700 Quality: ISO 9001, ISO 9002, CE Certified
Products: IV Fluids, IV Sets, General Sutures/Needles, Pressure Connector, Closed Male Connector, Diabetes Infusion Set, ...
ICU Medical, Inc. deals with safety medical systems. Our antimicrobial clave provides at least a 4-log bacterial kill rate for a continuous 96-hour use life. This method of manufacturing eliminates th more...
www.icumed.com | Send Inquiry | Phone: +1-(949)-366-2183, 800-824-7890
FDA Registration: 1713468 Year Established: 1984 Employee Count: ~1700 Quality: ISO 9001, ISO 9002, CE Certified
Products: IV Fluids, IV Sets, General Sutures/Needles, Pressure Connector, Closed Male Connector, Diabetes Infusion Set, ...
ICU Medical, Inc. deals with safety medical systems. Our antimicrobial clave provides at least a 4-log bacterial kill rate for a continuous 96-hour use life. This method of manufacturing eliminates th more...
Cardinal Health 303, Inc. | Address: 10020, Pacific Mesa Blvd., San Diego, California 92121, USA
Phone: +1-(858)-458-7830
FDA Registration: 2016493
Products: Oximeters (FDA Code: DQA), Oximeters, Blood Transfusion Sets (FDA Code: BRZ), Peristaltic Infusion Pump (FDA Code: FRN), Gaseous Phase Carbon-Dioxide Gas Analyzer (FDA Code: CCK), Gravity Flow Infusion Monitor (FDA Code: FLN), ...
Cardinal Health 303, Inc. offers blood transfusion sets, oximeters and peristaltic infusion pumps. more...
Phone: +1-(858)-458-7830
FDA Registration: 2016493
Products: Oximeters (FDA Code: DQA), Oximeters, Blood Transfusion Sets (FDA Code: BRZ), Peristaltic Infusion Pump (FDA Code: FRN), Gaseous Phase Carbon-Dioxide Gas Analyzer (FDA Code: CCK), Gravity Flow Infusion Monitor (FDA Code: FLN), ...
Cardinal Health 303, Inc. offers blood transfusion sets, oximeters and peristaltic infusion pumps. more...
S4J Manufacturing Services, Inc. | Address: 2685 N.E. 9th Avenue, Cape Coral, Florida 33909, USA
www.s4jluer.com | Send Inquiry | Phone: +1-(239)-574-9400, 888-S4J-LUER
Year Established: 1964 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001 Certified
Products: Luer Fittings, Luer Fitting Connector, Gas Manifold, Liquid Manifold, Contract Manufacturing, Durable Product Contract Manufacturing, ...
S4J Manufacturing Services, Inc. specializes in the production of ultra precision components, reusable luer lock connectors, quick connects, and miscellaneous adaptors. We are typically original equip more...
www.s4jluer.com | Send Inquiry | Phone: +1-(239)-574-9400, 888-S4J-LUER
Year Established: 1964 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 9001 Certified
Products: Luer Fittings, Luer Fitting Connector, Gas Manifold, Liquid Manifold, Contract Manufacturing, Durable Product Contract Manufacturing, ...
S4J Manufacturing Services, Inc. specializes in the production of ultra precision components, reusable luer lock connectors, quick connects, and miscellaneous adaptors. We are typically original equip more...
Baxter Healthcare Corp., Renal Division | Address: 7511 114th Avenue North, Largo, Florida 33777, USA
baxter.com | Send Inquiry | Phone: +1-(847)-948-2000
FDA Registration: 1036337
Products: Blood Transfusion Sets (FDA Code: BRZ), Blood Bank Supplies (FDA Code: KSS), Blood Mixing and Weighing Device (FDA Code: KSQ), Blood Transfer Unit (FDA Code: KSB), Blood & Components Collection Container (FDA Code: KSR), Automatic Delivery Peritoneal System (FDA Code: FKX), ...
Baxter Healthcare Corp., Renal Division develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, tr more...
baxter.com | Send Inquiry | Phone: +1-(847)-948-2000
FDA Registration: 1036337
Products: Blood Transfusion Sets (FDA Code: BRZ), Blood Bank Supplies (FDA Code: KSS), Blood Mixing and Weighing Device (FDA Code: KSQ), Blood Transfer Unit (FDA Code: KSB), Blood & Components Collection Container (FDA Code: KSR), Automatic Delivery Peritoneal System (FDA Code: FKX), ...
Baxter Healthcare Corp., Renal Division develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, tr more...
Advance Medical Designs, Inc. | Address: 1241 Atlanta Industrial Drive, Marietta, Georgia 30066, USA
www.advancemedicaldesigns.com | Send Inquiry | Phone: +1-(770)-422-3125, 800-221-3679
FDA Registration: 1037885 Year Established: 1984 Employee Count: ~70 Quality: ISO 9001, CE Certified
Products: Examination Drapes & Sheets, General Diagnostic Supplies, General Dressings, General Medical Supplies, General Surgical Aids, General OSHA Supplies, ...
Advance Medical Designs, Inc. manufactures and distributes disposable medical devices. We supply bag decanters for the aseptic transfer of fluids from flexible containers. We are accredited with ISO 9 more...
www.advancemedicaldesigns.com | Send Inquiry | Phone: +1-(770)-422-3125, 800-221-3679
FDA Registration: 1037885 Year Established: 1984 Employee Count: ~70 Quality: ISO 9001, CE Certified
Products: Examination Drapes & Sheets, General Diagnostic Supplies, General Dressings, General Medical Supplies, General Surgical Aids, General OSHA Supplies, ...
Advance Medical Designs, Inc. manufactures and distributes disposable medical devices. We supply bag decanters for the aseptic transfer of fluids from flexible containers. We are accredited with ISO 9 more...
Baxter International Inc | Address: One Baxter Parkway, Deerfield, Illinois 60015-4625, USA
www.baxter.com | Phone: +1-(847)-948-4770, 800-422-9837
FDA Registration: 2025695 Year Established: 1931
Products: Anesthesia Equipment, Ambulatory Pumps, Analgesics, Anesthesia, Anesthesia Delivery Unit, Anesthesia Equipment, ...
Baxter International Inc. provides medicines for hemophilia, immune disorders, kidney disease and cancer. We manufacture plasma-based and recombinant proteins used to treat hemophilia. We offer biopha more...
www.baxter.com | Phone: +1-(847)-948-4770, 800-422-9837
FDA Registration: 2025695 Year Established: 1931
Products: Anesthesia Equipment, Ambulatory Pumps, Analgesics, Anesthesia, Anesthesia Delivery Unit, Anesthesia Equipment, ...
Baxter International Inc. provides medicines for hemophilia, immune disorders, kidney disease and cancer. We manufacture plasma-based and recombinant proteins used to treat hemophilia. We offer biopha more...
Sponsored Links
FDA Code / Regulation: FMG / 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.
