AMMA

Basic Information

• Brand Name: AMMA
• Primary DI: 00850051245017
• Version / Model: Accessory Kit, Small, 1-pack
• Catalog Number: 831058
• Company Name: Cooler Heads Care, Inc.
• Labeler DUNS: 116482614
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-24
• Public Version: 1
• Public Version Date: 2023-11-01
• Public Version Status: New
• Public Device Record Key: 81ea0aa6-2366-48fa-b864-7d6c21841ea6

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMC	Scalp Cooling System	General, Plastic Surgery	878.4360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62231	Scalp cooling system	An assembly of mains electricity (AC-powered) devices intended to reduce scalp hair loss associated with intravenous chemotherapy treatment by cooling the scalp to cause vasoconstriction and reduction of chemotherapy drug uptake by the follicular cells. It consists of a control unit which pumps a cooling agent to a head-worn cap containing coolant channels and temperature monitoring sensors. An insulating cap (e.g., neoprene) may be worn over the cooling cap to secure it and prevent condensation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850051245017	GS1
Package	10850051245014	GS1	Pack	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K211526	000