Fibrinotherm

Basic Information

• Brand Name: Fibrinotherm
• Primary DI: 05413760308371
• Version / Model: 0600047
• Catalog Number: 0600047
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 005146311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 6
• Public Version Date: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: 39074d91-7ab7-4f55-9420-fca8821f5556

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRG	BLOCK, HEATING	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15178	Laboratory shaker	An electromechanical device, typically used in the laboratory or a blood bank, designed to shake/stir samples or mixtures with a rapid and forceful movement. It is used to provide a rapid mixing or to prevent substances comprised of different components from separation or sedimentation because of their different densities. It may be designed to secure single and/or multiple specimen containers (e.g., test tube, microplate) or specimen container holders during the shaking cycle; some types may have selectable agitation frequencies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	55413760308376	GS1	CASE	1	In Commercial Distribution
Primary	05413760308371	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 104 Degrees Fahrenheit