Global Hemostasis - HN

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name: Global Hemostasis - HN FDA UDI
Generic Name: Multiple coagulation factor IVD, reagent FDA UDI
Device Name: CITRATED: K, KH, RTH, FFH FDA UDI
Model / Reference: 07-604-US FDA UDI
Description: CITRATED: K, KH, RTH, FFH FDA UDI

Identifiers

Primary DI / UDI-DI: 10812747018531 FDA UDI
510(k) Number: K232018 FDA UDI
FDA Product Code: JPA FDA UDI
GMDN Term: Multiple coagulation factor IVD, reagent 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple coagulation factor IVD, reagent

Global Hemostasis - HN by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Haemonetics Corporation

Sources (1)

FDA UDI a6aaf991-95da-4bae-8f41-7e04ce6ffe14 36 fields · synced Jun 8, 2026