BRZ · Set, Blood Transfusion
General Hospital · 21 CFR 880.5440 · Class 2
Overview
| Product Code | BRZ |
|---|---|
| Device Name | Set, Blood Transfusion |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
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 Rationale
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.
Special Controls
*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.
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220558 | Blood Administration Sets | Baxter Healthcare Corporation | Nov 17, 2022 | SESE |
| K210335 | Blood Administration Set | Baxter Healthcare Corporation | Jun 10, 2021 | SESE |
| K132905 | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | Arteriocyte Medical Systems, Inc. | Oct 4, 2013 | SESE |
| K083349 | BLOOD TRANSFUSION SET | Shan Dong Wei Gao Group Medical Polymer Products | Apr 10, 2009 | SESE |
| K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR | Fenwal, Inc. | Mar 3, 2008 | SESE |
| K041496 | PENTATRASFU BLOOD TRANSFUSION SETS | Pentaferte S.P.A | Jun 30, 2005 | SESE |
| K050805 | 30 ML OR 60 ML PEDI-SYRINGE FILTER | Blood Products Specialties, LLC | Jun 20, 2005 | SESE |
| K050115 | BLOOD HAND PUMP ADMINISTRATION SET | Cardinal Health, Alaris Products | Apr 1, 2005 | SESE |
| K023039 | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 | Tuta Healthcare Pty Limited | Nov 7, 2002 | SESE |
| K000685 | CHARTER MEDICAL NEONATAL SYRINGE SET | Charter Medical, Ltd. | Aug 15, 2000 | SESE |
| K993120 | MODIFIED BLOOD RECIPIENT SET | Baxter Healthcare Corp | Nov 17, 1999 | SESE |
| K972843 | PROTOS BLOOD TRANSFUSION SET | Globe Ent., Inc. | Dec 16, 1997 | SESE |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Puritas Health Care, Inc. | Apr 21, 1994 | SESE |
| K940055 | MULTISET | Puritas Health Care, Inc. | Apr 15, 1994 | SESE |
| K921595 | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 | Haemotronic, Inc. | Dec 24, 1992 | SESE |
| K920788 | BLOOD ADMINISTRATION SET | Douglas Medical Products Corp. | Jun 4, 1992 | SESE |
| K880174 | JMS TRANSFUSION SET | Jms Co., Ltd. | Feb 16, 1988 | SESE |
| K871908 | IV ADMINISTRATION SET | Travenol Laboratories, S.A. | Jul 27, 1987 | SESE |
| K864441 | CHURCHILL BLOOD ADMINISTRATION SET | Churchill Corp. | Jan 20, 1987 | SESE |
| K861523 | STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) | Jufrey Multimed Corp. | May 27, 1986 | SESE |
Top Applicants
- Baxter Healthcare Corporation — 2 clearances
- Puritas Health Care, Inc. — 2 clearances
- The Boston Medical Group — 2 clearances
- Alpha Therapeutic Corp. — 1 clearance
- Amkor Trading Co. — 1 clearance
