Product code BRZ
- Device name
- Set, Blood Transfusion
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220558 | Blood Administration Sets | Baxter Healthcare Corporation | 2022-11-17 |
| K210335 | Blood Administration Set | Baxter Healthcare Corporation | 2021-06-10 |
| K132905 | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | Arteriocyte Medical Systems, Inc. | 2013-10-04 |
| K083349 | BLOOD TRANSFUSION SET | Shan Dong Wei Gao Group Medical Polymer Products | 2009-04-10 |
| K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR | Fenwal, Inc. | 2008-03-03 |
| K041496 | PENTATRASFU BLOOD TRANSFUSION SETS | Pentaferte S.P.A | 2005-06-30 |
| K050805 | 30 ML OR 60 ML PEDI-SYRINGE FILTER | Blood Products Specialties, LLC | 2005-06-20 |
| K050115 | BLOOD HAND PUMP ADMINISTRATION SET | Cardinal Health, Alaris Products | 2005-04-01 |
| K023039 | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 | Tuta Healthcare Pty Limited | 2002-11-07 |
| K000685 | CHARTER MEDICAL NEONATAL SYRINGE SET | Charter Medical, Ltd. | 2000-08-15 |
| K993120 | MODIFIED BLOOD RECIPIENT SET | Baxter Healthcare Corp | 1999-11-17 |
| K972843 | PROTOS BLOOD TRANSFUSION SET | Globe Ent., Inc. | 1997-12-16 |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Puritas Health Care, Inc. | 1994-04-21 |
| K940055 | MULTISET | Puritas Health Care, Inc. | 1994-04-15 |
| K921595 | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 | Haemotronic, Inc. | 1992-12-24 |
| K920788 | BLOOD ADMINISTRATION SET | Douglas Medical Products Corp. | 1992-06-04 |
| K880174 | JMS TRANSFUSION SET | Jms Co., Ltd. | 1988-02-16 |
| K871908 | IV ADMINISTRATION SET | Travenol Laboratories, S.A. | 1987-07-27 |
| K864441 | CHURCHILL BLOOD ADMINISTRATION SET | Churchill Corp. | 1987-01-20 |
| K861523 | STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) | Jufrey Multimed Corp. | 1986-05-27 |
| K854562 | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I | Medelec Intl. Corp. | 1986-01-09 |
| K852167 | ISOVOL-EXCHANGE TRAY | Rocky Mountain Medical Corp. | 1985-11-18 |
| K853386 | MULTISET 40 | Migada, Ltd. | 1985-08-22 |
| K851477 | VYGON EXCHANGE TRANSFUSION TRAY 275.00 | Vygon Corp. | 1985-05-03 |
| K841561 | HESUNG'S BLOOD DONOR SETS | Amkor Trading Co. | 1984-08-30 |
| K841187 | BLOOD COLLECTION SET, STERILE, DISPOS. | Marbex, Inc. | 1984-06-22 |
| K840411 | BLOOD & PLASMA ADMIN. DEV-STERILE | Loversan | 1984-03-19 |
| K833294 | ALPHA Y-RECIPIENT SET | Alpha Therapeutic Corp. | 1983-12-27 |
| K822410 | BOSTON BLOOD DONOR SETS | The Boston Medical Group | 1982-09-30 |
| K822409 | BOSTON BLOOD TRANSFUSION SETS | The Boston Medical Group | 1982-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M68980801R120 | Fresh Whole Blood Recipient Set | Safeguard US Operating, LLC | 2026-05-04 |
| M68980875100 | Low Titer Type O FWB Transfusion Set | Safeguard US Operating, LLC | 2025-02-09 |
| M68980801R100 | Fresh Whole Blood Recipient Set | Safeguard US Operating, LLC | 2024-12-16 |
| 00085412653303 | EXTENSION SET | BAXTER HEALTHCARE CORPORATION | 2021-12-23 |
| 00817827022081 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827022074 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827022067 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827022050 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827022043 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827022036 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827022029 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00817827022012 | N/A | CHARTER MEDICAL, LTD. | 2016-09-24 |
| 00085412079530 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412074832 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412073583 | INTERLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412072999 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412072982 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412068152 | INTERLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412049083 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412049076 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412046341 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412046129 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412044811 | INTERLINK | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412013770 | INTERLINK | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412004136 | NA | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412004006 | INTERLINK | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00085412002408 | INTERLINK | BAXTER INTERNATIONAL INC. | 2016-09-24 |
| 00811137010400 | NA | FENWAL, INC. | 2016-09-12 |
| 00811137010455 | NA | FENWAL, INC. | 2016-09-12 |
| 00811137010691 | NA | FENWAL, INC. | 2016-09-12 |