FDA Product Code
FDA Product Code BRZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220558 | Blood Administration Sets | Baxter Healthcare Corporation | 2022-11-17 | Traditional | PDF ↗ |
| K210335 | Blood Administration Set | Baxter Healthcare Corporation | 2021-06-10 | Traditional | PDF ↗ |
| K132905 | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | Arteriocyte Medical Systems, Inc. | 2013-10-04 | Traditional | PDF ↗ |
| K083349 | BLOOD TRANSFUSION SET | Shan Dong Wei Gao Group Medical Polymer Products | 2009-04-10 | Traditional | PDF ↗ |
| K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR | Fenwal, Inc. | 2008-03-03 | Traditional | PDF ↗ |
| K041496 | PENTATRASFU BLOOD TRANSFUSION SETS | Pentaferte S.P.A | 2005-06-30 | Abbreviated | PDF ↗ |
| K050805 | 30 ML OR 60 ML PEDI-SYRINGE FILTER | Blood Products Specialties, LLC | 2005-06-20 | Traditional | PDF ↗ |
| K050115 | BLOOD HAND PUMP ADMINISTRATION SET | Cardinal Health, Alaris Products | 2005-04-01 | Traditional | PDF ↗ |
| K023039 | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 | Tuta Healthcare Pty Limited | 2002-11-07 | Traditional | PDF ↗ |
| K000685 | CHARTER MEDICAL NEONATAL SYRINGE SET | Charter Medical, Ltd. | 2000-08-15 | Traditional | PDF ↗ |
| K993120 | MODIFIED BLOOD RECIPIENT SET | Baxter Healthcare Corp | 1999-11-17 | Traditional | PDF ↗ |
| K972843 | PROTOS BLOOD TRANSFUSION SET | Globe Ent., Inc. | 1997-12-16 | Traditional | PDF ↗ |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Puritas Health Care, Inc. | 1994-04-21 | Traditional | PDF ↗ |
| K940055 | MULTISET | Puritas Health Care, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K921595 | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 | Haemotronic, Inc. | 1992-12-24 | Traditional | PDF ↗ |
| K920788 | BLOOD ADMINISTRATION SET | Douglas Medical Products Corp. | 1992-06-04 | Traditional | PDF ↗ |
| K880174 | JMS TRANSFUSION SET | Jms Co., Ltd. | 1988-02-16 | Traditional | PDF ↗ |
| K871908 | IV ADMINISTRATION SET | Travenol Laboratories, S.A. | 1987-07-27 | Traditional | PDF ↗ |
| K864441 | CHURCHILL BLOOD ADMINISTRATION SET | Churchill Corp. | 1987-01-20 | Traditional | PDF ↗ |
| K861523 | STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) | Jufrey Multimed Corp. | 1986-05-27 | Traditional | PDF ↗ |
| K854562 | CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I | Medelec Intl. Corp. | 1986-01-09 | Traditional | PDF ↗ |
| K852167 | ISOVOL-EXCHANGE TRAY | Rocky Mountain Medical Corp. | 1985-11-18 | Traditional | PDF ↗ |
| K853386 | MULTISET 40 | Migada, Ltd. | 1985-08-22 | Traditional | PDF ↗ |
| K851477 | VYGON EXCHANGE TRANSFUSION TRAY 275.00 | Vygon Corp. | 1985-05-03 | Traditional | PDF ↗ |
| K841561 | HESUNG'S BLOOD DONOR SETS | Amkor Trading Co. | 1984-08-30 | Traditional | PDF ↗ |
| K841187 | BLOOD COLLECTION SET, STERILE, DISPOS. | Marbex, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K840411 | BLOOD & PLASMA ADMIN. DEV-STERILE | Loversan | 1984-03-19 | Traditional | PDF ↗ |
| K833294 | ALPHA Y-RECIPIENT SET | Alpha Therapeutic Corp. | 1983-12-27 | Traditional | PDF ↗ |
| K822410 | BOSTON BLOOD DONOR SETS | The Boston Medical Group | 1982-09-30 | Traditional | PDF ↗ |
| K822409 | BOSTON BLOOD TRANSFUSION SETS | The Boston Medical Group | 1982-09-30 | Traditional | PDF ↗ |
Product code BRZ · Class II · General Hospital. Data: openFDA.