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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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Hemochron Whole Blood Coagulation System - 10711234520017

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 - 10711234515044

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 - 10711234515006

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 - 10711234510070

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 - 10711234510056

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 - 10711234510025

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

Centralized Configuration Manager Software - 10711234540121

Centralized Configuration Manager Software
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
000GCCM
In Commercial Distribution

  • 10711234540121 ()
000GCCM

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

Hemochron Whole Blood Microcoagulation System - 10711234540091

Electronic System Verification - Abnormal
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
JEA-QC
In Commercial Distribution

  • 10711234540091 ()
JEA-QC

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

Hemochron Whole Blood Microcoagulation System - 10711234540077

Electronic System Verification Kit
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HE-J04
In Commercial Distribution

  • 10711234540077 ()
HE-J04

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

Hemochron Whole Blood Coagulation System - 10711234540053

Electronic System Verification Tube
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HE-ESV
In Commercial Distribution

  • 10711234540053 ()
HE-ESV

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

Hemochron Whole Blood Microcoagulation System - 10711234540039

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 - 10711234520055

Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Loaner)
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRS.110-L
In Commercial Distribution

  • 10711234520055 ()
HRS.110-L

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

Hemochron Whole Blood Microcoagulation System - 10711234510018

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

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

Dade Actin FSL Activated PTT Reagent - 00630414640358

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

Dade Actin FS Activated PTT Reagent - 00630414640341

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

Dade Actin FS Activated PTT Reagent - 00630414640327

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

Dade Actin FSL Activated PTT Reagent - 00630414640242

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

Dade® Actin® FSL Activated PTT Reagent - 00842768003882

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

Dade® Actin® FSL Activated PTT Reagent - 00842768003875

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

Dade® Actin® FS Activated PTT Reagent - 00842768003868

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445712
In Commercial Distribution

  • 00842768003868 ()
  • 00842768019562 ()
B4218-20

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003844

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445710
In Commercial Distribution

  • 00842768003844 ()
  • 00842768019562 ()
B4218-100

  • Activated partial thromboplastin time (APTT) IVD, reagent

Combined Adapter - 00850034511016

The Puregraft Combined Adapter is an autoclavable, reusable medical device used for the transfer of soft tissue and fluid between syringes and Puregraft products during general surgical and plastic surgery procedures.
Bimini Technologies LLC
ADAPT/PURE
In Commercial Distribution

  • 00850034511016 ()


  • Collection syringe adaptor, reusable

Anterior Disc Prep - 10889981189334

ALIF Modular Distractor Tip - 9mm
Seaspine Orthopedics Corporation
95-6193
In Commercial Distribution

  • 10889981189334 ()
95-6193

  • Collection syringe adaptor, single-use

Anterior Disc Prep - 10889981189327

ALIF Modular Distractor Tip - 8mm
Seaspine Orthopedics Corporation
95-6192
In Commercial Distribution

  • 10889981189327 ()
95-6192

  • Collection syringe adaptor, reusable

STRADIS HEALTHCARE - M75257032290

No Description
STRADIS MEDICAL, LLC
570-3229
Not in Commercial Distribution

  • M75257032290 ()


  • Collection syringe adaptor, single-use

Marina Medical - 00840306809828

Power Adapter, 60cc Monoject
MARINA MEDICAL INSTRUMENTS, INC.
800-180
In Commercial Distribution

  • 00840306809828 ()
800-180

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809811

Power Adapter, 20cc BD
MARINA MEDICAL INSTRUMENTS, INC.
800-175
In Commercial Distribution

  • 00840306809811 ()
800-175

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809804

Clicker Lock, 60cc Monoject and BD
MARINA MEDICAL INSTRUMENTS, INC.
800-170CLICK
In Commercial Distribution

  • 00840306809804 ()
800-170CLICK

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809798

Twist Lock, 60cc Monoject
MARINA MEDICAL INSTRUMENTS, INC.
800-170
In Commercial Distribution

  • 00840306809798 ()
800-170

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809781

Clicker Lock, 35cc Monoject
MARINA MEDICAL INSTRUMENTS, INC.
800-169CLICK
In Commercial Distribution

  • 00840306809781 ()
800-169CLICK

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809774

Twist Lock 35cc, Monoject
MARINA MEDICAL INSTRUMENTS, INC.
800-169
In Commercial Distribution

  • 00840306809774 ()
800-169

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809767

Clicker Lock 10cc Monoject
MARINA MEDICAL INSTRUMENTS, INC.
800-168CLICK
In Commercial Distribution

  • 00840306809767 ()
800-168CLICK

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809750

Clicker Lock 30cc BD
MARINA MEDICAL INSTRUMENTS, INC.
800-166CLICK
In Commercial Distribution

  • 00840306809750 ()
800-166CLICK

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809743

Clicker Lock, 20cc BD
MARINA MEDICAL INSTRUMENTS, INC.
800-165CLICK
In Commercial Distribution

  • 00840306809743 ()
800-165CLICK

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809736

Twist Lock, 20cc BD
MARINA MEDICAL INSTRUMENTS, INC.
800-165
In Commercial Distribution

  • 00840306809736 ()
800-165

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809729

Clicker Lock, 10cc BD
MARINA MEDICAL INSTRUMENTS, INC.
800-164CLICK
In Commercial Distribution

  • 00840306809729 ()
800-164CLICK

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809712

Twist Lock 10cc BD
MARINA MEDICAL INSTRUMENTS, INC.
800-164
In Commercial Distribution

  • 00840306809712 ()
800-164

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809699

Luer Lock to Christmas Tree Handle
MARINA MEDICAL INSTRUMENTS, INC.
800-162
In Commercial Distribution

  • 00840306809699 ()
800-162

  • Collection syringe adaptor, reusable

Marina Medical - 00840306809675

Toomey Power Handle 60cc
MARINA MEDICAL INSTRUMENTS, INC.
800-160
In Commercial Distribution

  • 00840306809675 ()
800-160

  • Collection syringe adaptor, reusable
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