BRZ — Set, Blood Transfusion Class II
FDA product code BRZ covers "Set, Blood Transfusion", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BRZ
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220558 | baxter healthcare corporation | Blood Administration Sets | November 17, 2022 |
| K210335 | baxter healthcare corporation | Blood Administration Set | June 10, 2021 |
| K132905 | arteriocyte medical systems | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | October 4, 2013 |
| K083349 | shan dong wei gao group medical polymer products | BLOOD TRANSFUSION SET | April 10, 2009 |
| K073339 | fenwal | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SI | March 3, 2008 |
| K041496 | pentaferte | PENTATRASFU BLOOD TRANSFUSION SETS | June 30, 2005 |
| K050805 | blood products specialties | 30 ML OR 60 ML PEDI-SYRINGE FILTER | June 20, 2005 |
| K050115 | cardinal health, alaris products | BLOOD HAND PUMP ADMINISTRATION SET | April 1, 2005 |
| K023039 | tuta healthcare pty limited | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 | November 7, 2002 |
| K000685 | charter medical | CHARTER MEDICAL NEONATAL SYRINGE SET | August 15, 2000 |
| K993120 | baxter healthcare | MODIFIED BLOOD RECIPIENT SET | November 17, 1999 |
| K972843 | globe ent | PROTOS BLOOD TRANSFUSION SET | December 16, 1997 |
| K940074 | puritas health care | Y-TYPE BLOOD ADMINISTRATION SET | April 21, 1994 |
| K940055 | puritas health care | MULTISET | April 15, 1994 |
| K921595 | haemotronic | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 | December 24, 1992 |
| K920788 | douglas medical products | BLOOD ADMINISTRATION SET | June 4, 1992 |
| K880174 | jms co | JMS TRANSFUSION SET | February 16, 1988 |
| K871908 | travenol laboratories | IV ADMINISTRATION SET | July 27, 1987 |
| K864441 | churchill | CHURCHILL BLOOD ADMINISTRATION SET | January 20, 1987 |
| K861523 | jufrey multimed | STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) | May 27, 1986 |