AccessGUDID - DEVICE: PSCS (B561PSCS1115VPFU0)

GUDID

Device Identifier (DI) Information

Brand Name: PSCS
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PSCS1 110V-PFU
Company Name: PAXMAN COOLERS LIMITED

Primary DI Number: B561PSCS1115VPFU0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 519917264 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62231	Scalp cooling system, hair loss	An assembly of electrically-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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMC	Scalp Cooling System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163484	000
K173032	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85a8930c-52cf-480a-903a-57a63655443b
Public Version Date: May 16, 2025
Public Version Number: 7
DI Record Publish Date: March 29, 2018