Hemochron Whole Blood Coagulation System HRS.110-L

GUDID 10711234520055

Hemochron Whole Blood Coagulation System - Hemochron Response Instrument (Loaner)

ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Coagulation analyser IVD, point-of-care, line-powered
Primary Device ID10711234520055
NIH Device Record Key4c5cc17f-e702-4290-b27f-b08cfc3a6379
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemochron Whole Blood Coagulation System
Version Model NumberHRS.110-L
Catalog NumberHRS.110-L
Company DUNS079299318
Company NameACCRIVA DIAGNOSTICS HOLDINGS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone1-800-678-0710
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
GS110711234520055 [Primary]

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 Number5
Public Version Date2022-08-31
Device Publish Date2016-09-22

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