Paxman Cooling Cap

GUDID B561PSCSCAPLARGE0

PAXMAN COOLERS LIMITED

Scalp cooling system

• Primary Device ID: B561PSCSCAPLARGE0
• NIH Device Record Key: 61ea7890-417a-43a8-b7db-fab504bcb607
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paxman Cooling Cap
• Version Model Number: Large
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B561PSCSCAPLARGE0 [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: 2018-04-05

On-Brand Devices [Paxman Cooling Cap]

• B561PSCSCAPSMALL0: Small
• B561PSCSCAPMEDIUM0: Medium
• B561PSCSCAPLARGE0: Large
• B561CAPSIZINGPACK1: Sizing pack
• B561PSCSCAPASIANSMALL0: Small Asian
• B561PSCSCAPASIANMEDIUM0: Medium Asian
• B561PSCSCAPASIANLARGE0: Large Asian
• B561PSCSCAPMEDSML0: Medium/Small
• B561CAPSIZINGPACKA1: Sizing pack Asian
• B561CAPBATCH1: Cap Batch