AccessGUDID - DEVICE: Paxman Cooling Cap (B561PSCSCAPMEDSML0)

GUDID

Device Identifier (DI) Information

Brand Name: Paxman Cooling Cap
Version or Model: Medium/Small
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PSCS-CAP-M/S
Company Name: PAXMAN COOLERS LIMITED

Primary DI Number: B561PSCSCAPMEDSML0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 519917264 *Terms of Use

Device Description: Paxman Cooling Cap which consists of a silicone inner layer and neoprene outer cover that connects to the Paxman Scalp Cooling System (PSCS) to provide scalp cooling treatment.

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":	No
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: 94ea977f-57e8-4e1c-9f1f-29838f297c3c
Public Version Date: May 16, 2025
Public Version Number: 4
DI Record Publish Date: March 07, 2022