TEG6s HEMOSTASIS SYSTEM

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name: TEG6s HEMOSTASIS SYSTEM FDA UDI
Generic Name: Coagulation analyser IVD, laboratory FDA UDI
Device Name: TEG 6S UNIT PACK FDA UDI
Model / Reference: 07-690-US FDA UDI
Description: TEG 6S UNIT PACK FDA UDI

Identifiers

Primary DI / UDI-DI: 30812747018351 FDA UDI
510(k) Number: K140893 FDA UDI
FDA Product Code: JOZ FDA UDI
GMDN Term: Coagulation analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Coagulation analyser IVD, laboratory

TEG6s HEMOSTASIS SYSTEM by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Coagulation analyser IVD, laboratory.

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Cleared under the same submission

K140893 also covers:

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 aad9c4d0-e7ea-4fd8-83ff-c159c1819f6f 35 fields · synced Jun 6, 2026