Hemochron Whole Blood Coagulation System HR1003

GUDID 10711234540060

Temperature Verification Tube

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Coagulation analyser IVD, laboratory, semi-automated
Primary Device ID10711234540060
NIH Device Record Keybab5c724-4742-4355-8e19-22c244cf1685
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemochron Whole Blood Coagulation System
Version Model NumberHR1003
Catalog NumberHR1003
Company DUNS079299318
Company NameACCRIVA DIAGNOSTICS HOLDINGS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-643-1640
EmailUDI@accriva.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com
Phone1-800-678-0710
Emaililsd_ra.na@werfen.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110711234540060 [Primary]
GS110711234540114 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPASystem, Multipurpose For In Vitro Coagulation Studies

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-04-28
Device Publish Date2020-04-08

On-Brand Devices [Hemochron Whole Blood Coagulation System]

10711234540060Temperature Verification Tube
10711234540053Electronic System Verification Tube
10711234540022Data Manager V3.0
10711234520062Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Demonstration)
10711234520055Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Loaner)
10711234520048Hemochron Whole Blood Coagulation System - Hemochron Response Instrument Refurbished
10711234520017Hemochron Whole Blood Coagulation System - Hemochron Response Instrument
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10711234202104Kaolin Protamine Response Test 40 tubes/box
10711234202098Kaolin Protamine Response Test 40 tubes/box
10711234202081Kaolin Heparin Response Test 40 tubes/box
10711234202067Celite Protamine Response Test 40 tubes/box
10711234202050Celite Protamine Response Test 40 tubes/box
10711234202036Heparin Response Test 40 tubes/box
10711234102206ACT Whole Blood Quality Control 40/box
10711234102183RxDx Whole Blood Quality Control Protamine 40/box
10711234102176RxDx Whole Blood Quality Control Heparin 40/box
10711234101391Kaolin ACT Tubes - 95 tubes/box
10711234101384Celite ACT Tubes - 95 tubes/box
10711234101230Celite Protamine Dose Assay - 40 tubes/box
10711234101094ACT Tubes 95 tubes/box
10711234540114Temperature Verification Tube

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