PSCS Coolant

GUDID B561COOLANTCOMMPACK1

PAXMAN COOLERS LIMITED

Scalp cooling system

• Primary Device ID: B561COOLANTCOMMPACK1
• NIH Device Record Key: b6f2d94c-fd47-408b-b7bb-a11fb6241177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSCS Coolant
• Version Model Number: Comm Pack
• 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com
• Phone: 844-572-9626
• Email: patient@paxmanusa.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B561COOLANTCOMMPACK1 [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