HemoTemp II

Basic Information

• Brand Name: HemoTemp II
• Primary DI: M74430001
• Version / Model: 3000
• Company Name: BIOSYNERGY, INC.
• Labeler DUNS: 070698154
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2017-02-08
• Public Version: 6
• Public Version Date: 2022-02-14
• Public Version Status: Update
• Public Device Record Key: d717e357-47c5-492c-94b2-41c2e048f30e
• Distribution End Date: 2022-02-12

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
KSS	Supplies, Blood-Bank	Hematology	864.9050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60964	Medical product temperature point indicator, thermochemical	A small device intended to be attached to a bag containing a temperature-sensitive medical product (e.g., blood, pharmaceutical) to indicate, by non-reversible chemical colour change, when a predetermined temperature is reached and exceeded, potentially making the product non-viable. It typically consists of a self-adhesive plastic container that holds a patch of heat-sensitive material which is activated when the container is attached to the product of interest. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M74430001	HIBCC
Package	M74430002	HIBCC	Case	5	Not in Commercial Distribution	2022-02-12
Unit of Use	M74430000	HIBCC

Customer Contacts

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