Supplies, Blood-bank
Hematology · 21 CFR 864.9050
Recent MDR events
72 adverse event reports on file
- TERUMO SAMPLING SITE COUPLERApr 30, 2026MalfunctionTerumo Corporation9681839-2026-00036
- TERUMO SAMPLING SITE COUPLERMar 16, 2026MalfunctionTerumo Corporation9681839-2026-00019
- NSTRIDE APS KIT WITH ACD-AFeb 23, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-00411
- GPS III PLATELET CONCENTRATION SYSTEMAug 25, 2025MalfunctionBiomet, Inc.MW5175191
- GPS III PLATELET CONCENTRATION SYSTEMJul 24, 2025MalfunctionZimmer Biomet, Inc.0001825034-2025-02218
- SPECIMEN DILUENTNov 26, 2024MalfunctionImmucor, Inc.1034569-2024-00021
- FENWAL SAMPLING SITE COUPLERDec 14, 2021MalfunctionFresenius Kabi / Fenwal International, Inc.MW5106054
- GPS MINI KIT W /ACD-A & BD -A/BLOOD DOct 11, 2021InjuryZimmer Biomet, Inc.0001825034-2021-02837
- GPS III MINI KIT W/30ML ACDASep 15, 2020MalfunctionZimmer Biomet, Inc.0001825034-2020-03488
- GPS III SINGLE KIT W/30ML ACDAJun 5, 2020MalfunctionZimmer Biomet, Inc.0001825034-2020-02229
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
67 firms currently registered for this product code
Web Industries
Dayville, CT, US
Micro Typing Systems, Inc.
POMPANO BEACH, FL, US
Fenwal, Inc.
LAKE ZURICH, IL, US
Typenex Medical, Llc
Chicago, IL, US
Clinico Medical Sp. Z O.o.
Blonie/Miekinia Dolnoslaskie, PL
Shenzhen Lilian Precision Mould Manufacturing Co., Ltd.
Shenzhen City Guangdong, CN
Fresenius Hemocare Gmbh
Friedberg Hesse, DE
Ningbo Risenmed Technology Co.,ltd.
Ningbo Zhejiang, CN
Isomedix Operations, Inc.
Libertyville, IL, US
Baxter Healthcare Corporation
CLEVELAND, MS, US
Alpha Scientific Corp.
Exton, PA, US
Delcon Srl
Grassobbio Bergamo, IT
Itl Asia Pacific Sdn Bhd
Batu Gajah Perak, MY
Zebra Technologies Corporation
Morris Plains, NJ, US
Isomedix Operations, Inc.
Libertyville, IL, US
Immucor, Inc.
Norcross, GA, US
Terumo Bct, Inc..
Lakewood, CO, US
Kentec Medical, Inc.
Irvine, CA, US
Advanced Engineering, Inc.
Huntington, IN, US
Ashland Specialty Ingredients, G.p.
Bridgewater, NJ, US
Macoproductions S.a.s.
TOURCOING Nord, FR
Tessy Plastics Corp.
ELBRIDGE, NY, US
510(k) clearances
6 clearances for this product code
- U.S. Mfg. & Management, Inc.Jan 5, 1988
K874436 · FLUID SAMPLING PACK
- American DadeOct 27, 1981
K812892 · S/P SERUM DROPPER PIPETS
- Pre-Dent SystemJul 14, 1980
K801386 · PRE-DENT SYSTEM OR PRE-DENT II
- Pre-Dent SystemJul 14, 1980
K801516 · PRE-DENT SYSTEM MODIFIED
- Pre-Dent SystemApr 24, 1980
K800736 · PRE-DENT SYSTEM
- Dade, Baxter Travenol Diagnostics, Inc.Dec 30, 1976
K761303 · IMMU-SAL IMMUNOHEMATOLOGICAL SALINE