PSCS

GUDID B561PSCS1115VPFU0

The Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tested to IEC 60601 safety standards for medical devices.

PAXMAN COOLERS LIMITED

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• Primary Device ID: B561PSCS1115VPFU0
• NIH Device Record Key: 85a8930c-52cf-480a-903a-57a63655443b
• Commercial Distribution Discontinuation: 2023-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSCS
• Version Model Number: 1
• Company DUNS: 519917264
• Company Name: PAXMAN COOLERS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B561PSCS1115VPFU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163484

FDA Product Code

• PMC: Scalp Cooling System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-29

On-Brand Devices [PSCS]

• B561PSCS2115VPFU0: The Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tes
• B561PSCS1115VPFU0: The Paxman Scalp Cooling System (PSCS) is a compact, mobile refrigeration unit that has been tes