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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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KC® 1 Delta - 05391521421005

No Description
TCOAG IRELAND LIMITED
G05000
In Commercial Distribution

  • 05391521421005 ()


  • Coagulation analyser IVD, laboratory, semi-automated

Hemochron Whole Blood Coagulation System - 10711234540114

Temperature Verification Tube
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HR1003
In Commercial Distribution

  • 10711234540114 ()
HR1003

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory, semi-automated

HemosIL Rinse Solution (ACLFutura Advance) - 08426950553502

HemosIL Rinse Solution 2L (ACLFutura Advance)
INSTRUMENTATION LABORATORY COMPANY
00020302500
Not in Commercial Distribution

  • 08426950553502 ()
00020302500

  • Buffered sample diluent IVD, manual

HemosIL Rinse Solution (ACL TOP Family) - 08426950075882

HemosIL Rinse Solution (ACL TOP Family) 4000 mL
INSTRUMENTATION LABORATORY COMPANY
00020009700
Not in Commercial Distribution

  • 08426950075882 ()
00020009700

  • Buffered sample diluent IVD, manual

HemosIL Rinse Solution (ACL Futura Advance) - 08426950003083

HemosIL Rinse Solution (ACL Futura Advance) 2 LIT
INSTRUMENTATION LABORATORY COMPANY
00020009320
Not in Commercial Distribution

  • 08426950003083 ()
00020009320

  • Buffered sample diluent IVD, manual

BFT II Analyzer - 00842768024887

The BFT II Analyzer is a semi-automated device intended for use to determine PT, APTT and Fibrinogen
Siemens Healthcare Diagnostics Products GmbH
10458677
In Commercial Distribution

  • 00842768024887 ()
OVKF032

  • Coagulation analyser IVD, laboratory, semi-automated

Cuvettes for BFT // Analyzer - 00842768012358

The cuvettes serve coagulation tests as a reaction vessel.
Siemens Healthcare Diagnostics Products GmbH
10446541
In Commercial Distribution

  • 00842768012358 ()
  • 00842768025006 ()
OVMN11

  • Coagulation analyser IVD, laboratory, semi-automated

BFT II Analyzer Dispo System - 00842768012259

The cuvettes serve coagulation tests as a reaction vessel.
Siemens Healthcare Diagnostics Products GmbH
10446530
In Commercial Distribution

  • 00842768012259 ()
  • 00842768024979 ()
OVKG03

  • Coagulation analyser IVD, laboratory, semi-automated

ROTANTA 460 RF - 04050674078160

Floor standing centrifuge, refrigerated
Andreas Hettich GmbH & Co. KG
ROTANTA 460 RF - 100V-127V/50-60Hz
In Commercial Distribution

  • 04050674078160 ()
5675-01

  • Low-speed floor centrifuge, refrigerated

ROTANTA 460 RF - 04050674056960

Floor standing centrifuge, refrigerated
Andreas Hettich GmbH & Co. KG
ROTANTA 460 RF, 200-240V 50Hz
In Commercial Distribution

  • 04050674056960 ()
5675

  • Low-speed floor centrifuge, refrigerated
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