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Fibrinotherm

FDA UDI

Class I (US FDA UDI)

by Baxter International Inc.

Identity

Trade Name
Fibrinotherm FDA UDI
Generic Name
Laboratory shaker FDA UDI
Device Name
The FIBRINOTHERM Heating and Stirring Device is designed to facilitate the reconstitution of Baxter's two component Fibrin Sealant kit. The device consists of a heating block and an integrated magnetic stirrer. FDA UDI
Model / Reference
0600047 FDA UDI
Description
The FIBRINOTHERM Heating and Stirring Device is designed to facilitate the reconstitution of Baxter's two component Fibrin Sealant kit. The device consists of a heating block and an integrated magnetic stirrer. FDA UDI

Identifiers

Catalog Number
0600047 FDA UDI
Primary DI / UDI-DI
05413760308371 FDA UDI
FDA Product Code
JRG FDA UDI
GMDN Term
Laboratory shaker FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laboratory shaker

Fibrinotherm by Baxter International Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory shaker.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baxter International Inc.

Sources (1)

  • FDA UDI 39074d91-7ab7-4f55-9420-fca8821f5556 36 fields · synced May 30, 2026