THERMAWRAP ADULT HEAD COVER

Basic Information

• Brand Name: THERMAWRAP ADULT HEAD COVER
• Primary DI: 05059443003579
• Version / Model: AMTW1000
• Company Name: ARMSTRONG MEDICAL LTD
• Labeler DUNS: 239659915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-23
• Public Version: 1
• Public Version Date: 2023-05-31
• Public Version Status: New
• Public Device Record Key: 41988fe2-d7eb-4f66-a6d6-29f282dcc6cf

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: Yes
• 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
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16219	Hypothermia-prevention cap	A head covering in the form of a cap intended to be worn by a patient typically during conditions of low body temperature and/or long surgical procedures to minimize loss of body heat from the head. It typically includes a heat-reflecting inner metal surface to facilitate retention of body heat. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05059443003579	GS1

Customer Contacts

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