PSCS

Basic Information

• Brand Name: PSCS
• Primary DI: B561PSCS1115VPFU0
• Version / Model: 1
• Catalog Number: PSCS1 110V-PFU
• Company Name: PAXMAN COOLERS LIMITED
• Labeler DUNS: 519917264
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-29
• Public Version: 4
• Public Version Date: 2023-01-02
• Public Version Status: Update
• Public Device Record Key: 85a8930c-52cf-480a-903a-57a63655443b
• Distribution End Date: 2023-01-01

Device Description

The Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tested to IEC 60601 safety standards for medical devices. The unit circulates a refrigerated liquid coolant, at low pressure, through a special cooling cap that is positioned on the patient’s head. The circulation of the refrigerated coolant through the cap extracts heat from the patient’s scalp and maintains it at the optimum temperature for scalp cooling. There are two versions of the device. One is for single patient use, PSCS1, the other is for two patient use, PSCS2.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
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	B561PSCS1115VPFU0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K163484	000