Adult Heart Cooling Jacket

Basic Information

• Brand Name: Adult Heart Cooling Jacket
• Primary DI: 36641670001314
• Version / Model: 2.4
• Catalog Number: 17-260
• Company Name: Cardiomed Supplies Inc
• Labeler DUNS: 240623124
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 18
• Record Status: Published
• Publish Date: 2021-04-21
• Public Version: 1
• Public Version Date: 2021-04-29
• Public Version Status: New
• Public Device Record Key: 90125c0d-ea71-4e19-9993-f4b567b7e090

Device Description

The Heart Cooling Jacket is effective in controlling the temperature of the cardiac organ during an open heart surgery. The closed loop heat transfer system works to protect the cardiac organ.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64924	Cardiac arrest hypothermia kit	A collection of devices intended to lower the core body temperature of a patient in the short term following a cardiac arrest event to induce and sustain mild hypothermia for improvement of neurological and cognitive prognoses. It typically includes blankets, caps, axilla pads and groin pads, which are filled with a thermally-retentive material (e.g., non-toxic polymer gel) that can be cooled in a freezer. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	16641670001303	GS1
Primary	36641670001314	GS1

Premarket Submissions

Submission Number	Supplement Number
K833112	000