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Hemochron Whole Blood Coagulation System

FDA UDI

Class II (US FDA UDI)

by Accriva Diagnostics Holdings, Inc.

Identity

Trade Name
Hemochron Whole Blood Coagulation System FDA UDI
Generic Name
Coagulation analyser IVD, point-of-care, line-powered FDA UDI
Device Name
Data Manager V3.0 FDA UDI
Model / Reference
HRDM3CD FDA UDI
Description
Data Manager V3.0 FDA UDI

Identifiers

Catalog Number
HRDM3CD FDA UDI
Primary DI / UDI-DI
10711234540022 FDA UDI
FDA Product Code
JPA FDA UDI
GMDN Term
Coagulation analyser IVD, point-of-care, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coagulation analyser IVD, laboratoryCoagulation analyser IVD, point-of-care, line-powered

Hemochron Whole Blood Coagulation System by Accriva Diagnostics Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation analyser IVD, point-of-care, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accriva Diagnostics Holdings, Inc.

Sources (1)

  • FDA UDI d6541ce8-a812-4cca-96be-658f29f04f94 35 fields · synced Jun 6, 2026