Daily Cardiac Cooling Jacket

GUDID 00867673000306

The Daily Cardiac Cooling Jacket is a conformable heat exchanger which is placed around the heart during cardiopulmonary bypass procedures. By circulating cold physiologic saline through the jacket the heat is transferred from the heart to the solution thus reducing the heart temperature to provide myocardial preservation. The device is used as an alternative to iced slush for topical cardiac hypothermia.

DAILY MEDICAL PRODUCTS, INC

Cardiac insulation pad

• Primary Device ID: 00867673000306
• NIH Device Record Key: 1efed18e-934b-4c45-b5f4-76c000b04b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Daily Cardiac Cooling Jacket
• Version Model Number: C1116, C1123, C1130
• Company DUNS: 800432093
• Company Name: DAILY MEDICAL PRODUCTS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• 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: 763-550-1775
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867673000306 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-03-02