← Back to catalogue

Teg5000 Hemostasis Analyzer

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name
TEG5000 HEMOSTASIS ANALYZER FDA UDI
Generic Name
Blood viscoelasticity analyser IVD FDA UDI
Device Name
TEG ANALYZER 5000, 230V, 60HZ, FG FDA UDI
Model / Reference
07-066 FDA UDI
Description
TEG ANALYZER 5000, 230V, 60HZ, FG FDA UDI

Identifiers

Primary DI / UDI-DI
30812747018412 FDA UDI
510(k) Number
K993678 FDA UDI
FDA Product Code
JPA FDA UDI
GMDN Term
Blood viscoelasticity analyser IVD 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

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood viscoelasticity analyser IVD

Teg5000 Hemostasis Analyzer by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood viscoelasticity analyser IVD.

Cleared under the same submission

K993678 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Haemonetics Corporation

Sources (1)

  • FDA UDI 4eaa2b3a-4ff0-47c7-bffe-5a12de6d43ad 35 fields · synced Jun 8, 2026