Heart-Chill Cardiac & Phrenic Insulator

Basic Information

• Brand Name: Heart-Chill Cardiac & Phrenic Insulator
• Primary DI: B040CPIL14
• Version / Model: CPI-L
• Company Name: GENESEE BIOMEDICAL, INC.
• Labeler DUNS: 939872651
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ed4476fd-3fa8-4c3e-b9f8-9c64ec797fbb

Device Description

Cardiac & Phrenic Insulator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DWC	Controller, Temperature, Cardiopulmonary Bypass	Cardiovascular	870.4250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35973	Cardiac insulation pad	A thin and pliable cushion designed to be placed around the heart in conjunction with cold cardioplegia during cardiac surgery with extracorporeal circulation. The device is intended to help to prevent rapid rewarming of the heart. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B040CPIL25	HIBCC		1	In Commercial Distribution
Primary	B040CPIL14	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K874927	000