PSCS Coolant

GUDID B5611LCOOLANT0

PAXMAN COOLERS LIMITED

Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system Scalp cooling system

• Primary Device ID: B5611LCOOLANT0
• NIH Device Record Key: 13408cb0-bad8-48f6-a895-b73cb13da693
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSCS Coolant
• Version Model Number: 1L
• 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: true
• Serial Number: false
• 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	B5611LCOOLANT0 [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 [PSCS Coolant]

• B561COOLANTCOMMPACK1: Comm Pack
• B5613LCOOLANT0: 3L
• B5611LCOOLANT0: 1L
• B561COOLANTBATCH1: Coolant Batch