Paxman cap kit PSCS-KIT-L25

GUDID B561PSCSKITL251

PAXMAN COOLERS LIMITED

Scalp cooling system

• Primary Device ID: B561PSCSKITL251
• NIH Device Record Key: 5d6dd227-993d-4c69-874c-972dadf96e7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paxman cap kit
• Version Model Number: Large, 25 credits
• Catalog Number: PSCS-KIT-L25
• 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: true
• 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

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	B561PSCSKITL251 [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: 1
• Public Version Date: 2022-03-28
• Device Publish Date: 2022-03-18

On-Brand Devices [Paxman cap kit]

• B561PSCSKITSA251: Small Asian, 25 credits
• B561PSCSKITS251: Small, 25 credits
• B561PSCSKITMS251: Medium/Small, 25 credits
• B561PSCSKITMA251: Medium Asian, 25 credits
• B561PSCSKITM251: Medium, 25 credits
• B561PSCSKITLA251: Large Asian, 25 credits
• B561PSCSKITL251: Large, 25 credits