HemoTemp II

Basic Information

• Brand Name: HemoTemp II
• Primary DI: 00815236021060
• Version / Model: HemoTemp II
• Company Name: LCR HALLCREST, LLC.
• Labeler DUNS: 059247507
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-14
• Public Version: 1
• Public Version Date: 2022-02-22
• Public Version Status: New
• Public Device Record Key: f37e825e-f7d3-47dc-ad7b-5fffd220572a

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
Package	10815236021067	GS1	Box	40	In Commercial Distribution
Primary	00815236021060	GS1
Package	20815236021064	GS1	Case	5	In Commercial Distribution
Previous	M74430001	HIBCC

Customer Contacts

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