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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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ROTEM® - 04260160470587

The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System (US/CA)
In Commercial Distribution

  • 04260160470587 ()
201001

  • Coagulation analyser IVD, laboratory, semi-automated

ROTEM® - 04260160470020

The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.
Tem Innovations GmbH
delta System
In Commercial Distribution

  • 04260160470020 ()
200100-US

  • Coagulation analyser IVD, laboratory, semi-automated

KC® 4 Delta - 05391521421012

No Description
TCOAG IRELAND LIMITED
N04000
In Commercial Distribution

  • 05391521421012 ()


  • Coagulation analyser IVD, laboratory, semi-automated

KC® 1 Delta - 05391521421005

No Description
TCOAG IRELAND LIMITED
G05000
In Commercial Distribution

  • 05391521421005 ()


  • 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

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

ST art® - 03607450582307

No Description
DIAGNOSTICA STAGO
58230
In Commercial Distribution

  • 03607450582307 ()


  • Coagulation analyser IVD, laboratory, semi-automated

TEMPERATURE PROBE - 08426950452614

TEMPERATURE PROBE
INSTRUMENTATION LABORATORY COMPANY
06320480210
In Commercial Distribution

  • 08426950452614 ()
06320480210

  • Coagulation analyser IVD, laboratory, semi-automated

Sebacia Microparticles - G256SEB2503PUS1

Sebacia Microparticles Box of 9 vials
Coronado Aesthetics, LLC
SEB-250-3P-US
In Commercial Distribution

  • G256SEB2503PUS1 ()
  • G256SEB2503PUS0 ()

  • Total Volume: 3 Milliliter
SEB2503PUS

  • Photothermal therapy gel

Sebacia Microparticles - 20850002391019

Sebacia Microparticles ia a medical device consisting of engineered gold microparticles suspension intended for single use topical application. Sebacia Microparticles are designed to work as an accessory to a commercially available medically approved 1064nm laser by preferentially absorbing the light and converting it to heat, creating a focal thermal effect to the follicle and sebaceous gland for the treatment of acne vulgaris.
SEBACIA, INC.
SEB-250-3P-US
In Commercial Distribution

  • 20850002391019 ()
  • 10850002391111 ()

  • Total Volume: 3 Milliliter
SEB-250-3P-US

  • Photothermal therapy gel

STA® - PTT A 5 - 13607450005957

No Description
DIAGNOSTICA STAGO
00595
In Commercial Distribution

  • 13607450005957 ()
  • 03607450005950 ()


  • Activated partial thromboplastin time (APTT) IVD, kit, clotting

Bosma Enterprises - 00818634020307

Patient Transportation PTT Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Partially-Fitted Gurney Sheet, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.
Bosma Enterprises
10-9030PTT
In Commercial Distribution

  • 10818634020304 ()
  • 00818634020307 ()
10-9030PTT

  • Pillow cover, single-use
  • Basic bed sheet, single-use

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

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 - 10711234540107

Temperature Verification Cartridge
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
J-1001
In Commercial Distribution

  • 10711234540107 ()
J-1001

  • 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 - 10711234540084

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

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 - 10711234540060

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

HR1003

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

directCHECK Whole Blood Controls - 10711234540046

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

Hemochron Whole Blood Coagulation System - 10711234540022

Data Manager V3.0
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRDM3CD
In Commercial Distribution

  • 10711234540022 ()
HRDM3CD

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

Hemochron Whole Blood Coagulation System - 10711234520062

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 - 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 Coagulation System - 10711234520048

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 - 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

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

STRADIS HEALTHCARE - M75257032290

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

  • M75257032290 ()


  • Collection syringe adaptor, single-use

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

Marina Medical - 00840306800009

Micronizer 2.4mm, Box of 10
MARINA MEDICAL INSTRUMENTS, INC.
800-524
In Commercial Distribution

  • 00840306800009 ()

  • Length: 2.4 Millimeter
800-524

  • Collection syringe adaptor, reusable

Marina Medical - 00840306835216

Twist Lock 60cc, BD
MARINA MEDICAL INSTRUMENTS, INC.
800-171
In Commercial Distribution

  • 00840306835216 ()
800-171

  • Collection syringe adaptor, reusable

Marina Medical - 00840306835209

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

  • 00840306835209 ()
800-168

  • 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
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