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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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Electronic System Verification - Normal
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
JEN-QC
In Commercial Distribution

  • 10711234540084 ()
JEN-QC

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Temperature Verification Tube
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HR1003
In Commercial Distribution

HR1003

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Protective Sleeves
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
DCJ-005
In Commercial Distribution

  • 10711234540046 ()
DCJ-005

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Report Maker V6.01
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
RPM-CD
In Commercial Distribution

  • 10711234540039 ()
RPM-CD

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Demonstration)
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRS.110-D
In Commercial Distribution

  • 10711234520062 ()
HRS.110-D

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Coagulation System - Hemochron Response Instrument Refurbished
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRS.RF
In Commercial Distribution

  • 10711234520048 ()
HRS.RF

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Coagulation System - Hemochron Response Instrument
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRS.110
In Commercial Distribution

  • 10711234520017 ()
HRS.110

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
GEM Hemochron 100 System (Loaner)
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GH100L
In Commercial Distribution

  • 10711234515044 ()
000GH100L

  • Coagulation analyser IVD, laboratory
  • Coagulation analyser IVD, point-of-care, line-powered
GEM Hemochron 100 System - GEM Hemochron 100 Instrument
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GH100
In Commercial Distribution

  • 10711234515006 ()
000GH100

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (Loaner)
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
ELITEL
In Commercial Distribution

  • 10711234510070 ()
ELITEL

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (Demonstration)
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
ELITEDEMO
In Commercial Distribution

  • 10711234510056 ()
ELITEDEMO

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument Refurbished
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
ELITERF
In Commercial Distribution

  • 10711234510025 ()
ELITERF

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
Hemochron Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
ELITE
In Commercial Distribution

  • 10711234510018 ()
ELITE

  • Coagulation analyser IVD, point-of-care, line-powered
  • Coagulation analyser IVD, laboratory
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
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873832
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640358 ()
10873832

  • Activated partial thromboplastin time (APTT) IVD, reagent
Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873830
In Commercial Distribution

  • 00842768019562 ()
  • 00630414640341 ()
10873830

  • Activated partial thromboplastin time (APTT) IVD, reagent
Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873828
In Commercial Distribution

  • 00842768019562 ()
  • 00630414640327 ()
10873828

  • Activated partial thromboplastin time (APTT) IVD, reagent
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873831
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640242 ()
10873831

  • Activated partial thromboplastin time (APTT) IVD, reagent
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445714
In Commercial Distribution

  • 00842768003882 ()
  • 00842768019555 ()
B4219-2

  • Activated partial thromboplastin time (APTT) IVD, reagent
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445713
In Commercial Distribution

  • 00842768003875 ()
  • 00842768019555 ()
B4219-1

  • Activated partial thromboplastin time (APTT) IVD, reagent
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