Heart-Chill Cardiac & Phrenic Insulator

GUDID B040CPIS1

Cardiac & Phrenic Insulator

GENESEE BIOMEDICAL, INC.

Cardiac insulation pad Cardiac insulation pad

• Primary Device ID: B040CPIS1
• NIH Device Record Key: f7189504-056f-4630-9c85-43b5cf01b255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heart-Chill Cardiac & Phrenic Insulator
• Version Model Number: CPI-S
• Company DUNS: 939872651
• Company Name: GENESEE BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800 786-4890
• Email: info@geneseebiomedical.com
• Phone: 800 786-4890
• Email: info@geneseebiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B040CPIS1 [Primary]
HIBCC	B040CPIS2 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874927

FDA Product Code

• DWC: Controller, Temperature, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-01

On-Brand Devices [Heart-Chill Cardiac & Phrenic Insulator]

• B040CPIS1: Cardiac & Phrenic Insulator
• B040CPIL25: Cardiac & Phrenic Insulator