Separator, Automated, Blood Cell, Diagnostic

Product Code: GKT

Hematology In Vitro And Other Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10]

Code of Federal Regulations: 864.9245


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as GKT

2317Separator, Automated, Blood Cell, DiagnosticAutomated Blood Cell Separator.

Total Product Life Cycle (TPLC) Devices

2317Separator, Automated, Blood Cell, DiagnosticAutomated Blood Cell Separator.

Pre-market Notifications for GKT

BK200498Automated Blood Cell SeparatorsHaemonetics Corporation
BK200478Automated Blood Cell SeparatorsFresenius Kabi AG
BK200475Automated Blood Cell SeparatorsFenwal Inc
K200530AMICUS Separator SystemFresenius Kabi AG
BK190368Automated Blood Cell SeparatorsFresenius Kabi AG
BK190351Automated Blood Cell SeparatorsFresenius Kabi USA LLC.
BK190332Automated Blood Cell SeparatorsTerumo BCT, Inc
BK180268Automated Blood Cell SeparatorsFresenius Kabi AG
BK180231Automated Blood Cell SeparatorsTerumo BCT, Inc
BK180230Automated Blood Cell SeparatorsFresenius Kabi AG
BK180185Automated Blood Cell SeparatorsHaemonetics Corporation
BK170157Automated Blood Cell SeparatorsTerumo BCT, Inc
BK170099Automated Blood Cell SeparatorsFresenius Kabi USA LLC.
BK170072Automated Blood Cell SeparatorsFresenius Kabi AG
BK170059Automated Blood Cell SeparatorsTerumo BCT, Inc

Global Unique Device Identification Database

00811137012992Separator, Automated, Blood Cell, Diagnostic
00811137012916Separator, Automated, Blood Cell, Diagnostic
00811137010134Separator, Automated, Blood Cell, Diagnostic
10811137010124Separator, Automated, Blood Cell, Diagnostic
05020583810020Separator, automated, blood cell, diagnostic
05020583810013Separator, automated, blood cell, diagnostic
05020583810006Separator, automated, blood cell, diagnostic
05020583719002Separator, automated, blood cell, diagnostic
05020583711006Separator, automated, blood cell, diagnostic
05020583610002Separator, automated, blood cell, diagnostic
05020583300132Separator, automated, blood cell, diagnostic
04086000101967Separator, Automated, Blood Cell, Diagnostic
04086000101660Separator, Automated, Blood Cell, Diagnostic
04086000101653Separator, Automated, Blood Cell, Diagnostic
04086000101578Separator, Automated, Blood Cell, Diagnostic

Maude Adverse Events

PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
MCS?+ MOBILE COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
MCS?+ 9000 MOBILE PLATELET COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
MCS?+ MOBILE COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-30
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-27
CONC PLT & PLS SET W/FILTERHAEMONETICS CORPORATION2020-03-20
NEXSYS PCS, USHAEMONETICS CORPORATION2020-03-20
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-20
TRIMA ACCELTERUMO BCT2020-03-20
TRIMA ACCELTERUMO BCT2020-03-19
TRIMA ACCELTERUMO BCT2020-03-19
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-18
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-18
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-18
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-18
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-18
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-18
MCS?+ 8150 MULTICOMPONENT COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-18
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-17
NEXSYS PCS?HAEMONETICS CORPORATION2020-03-17
TRIMA ACCELTERUMO BCT2020-03-17
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-13
TRIMA ACCELTERUMO BCT2020-03-13
TRIMA ACCELTERUMO BCT2020-03-13
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
NEXSYS PCS?HAEMONETICS CORPORATION2020-03-12
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-12
TRIMA ACCELTERUMO BCT2020-03-10
NEXSYS PCS?HAEMONETICS CORPORATION2020-03-10
PCS?2 PLASMA COLLECTION SYSTEMHAEMONETICS CORPORATION2020-03-10

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