Device, Blood Mixing And Blood Weighing
Hematology · 21 CFR 864.9195
Recent MDR events
4 adverse event reports on file
- BOEKEL BLOOD COLLECTION MIXERSep 15, 2025MalfunctionBoekel Scientific.23051238
- GENESIS BPSApr 20, 2012MalfunctionGenesis Bps2545702
- ADJUSTABLE AUTOMATIC DONOR SCALEJul 11, 2000InjuryHighland Laboratories1036337-2000-00002
- ADJUSTABLE AUTOMATIC DONOR SCALEMar 15, 2000InjuryHighland Laboratories1036337-2000-00001
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
18 firms currently registered for this product code
Centron Corporation
Anyang-si Gyeonggi, KR
Fenwal, Inc.
LAKE ZURICH, IL, US
Fresenius Kabi Warrendale
WARRENDALE, PA, US
Infitek Co., Ltd.
Shanghai, CN
Remi Elektrotechnik Ltd.
Dist. Palghar Maharashtra, IN
Applied Science, Inc.
GRASS VALLEY, CA, US
Moeller Medical Gmbh
FULDA Hesse, DE
Boekel Scientific
Feasterville, PA, US
Labpeak Co.,ltd
Jinan Shandong, CN
Clinico Medical Sp. Z O.o.
Blonie/Miekinia Dolnoslaskie, PL
Marken Healthtech Limited
NASHIK Maharashtra, IN
Genesisbps Llc
Mahwah, NJ, US
Fresenius Hemocare Gmbh
Friedberg Hesse, DE
Mark Enterprises
Nashik Maharashtra, IN
P Bhogilal Pvt Ltd
Kolkata West Bengal, IN
Helmer Inc.
NOBLESVILLE, IN, US
Scitek Global Co.,ltd
Jinan Shandong, CN
510(k) clearances
8 clearances for this product code
- R&D Systems, Inc.Aug 17, 1984
K842746 · HYCEL ROTOR-MIXER AND/OR MULTI
- Separation Science Corp.May 7, 1982
K820712 · SEPCOR UNIT COLLECTION MONITOR
- Helmer Labs, Inc.Sep 29, 1981
K812533 · PLATELET AGITATOR
- Lifeline Instruments, Inc.Apr 7, 1981
K810617 · MOBILE MATIC AUTOMATIC DONOR SCALE
- Helmer Labs, Inc.Dec 11, 1980
K802608 · HEMATIC BLOOD MIXER
- Royco InstrumentsFeb 6, 1980
K800104 · ROYCO MODEL 951 CELL MIXER
- Travenol Laboratories, S.A.Mar 30, 1978
K780189 · PLATELET ROTATOR
- Lifeline Instruments, Inc.Dec 6, 1976
K760743 · DONORMATIC (BLOOD COLLECTION DEVICE)