AccessGUDID - DEVICE: Heart-Chill Cardiac & Phrenic Insulator (B040CPIS1)

GUDID

Device Identifier (DI) Information

Brand Name: Heart-Chill Cardiac & Phrenic Insulator
Version or Model: CPI-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENESEE BIOMEDICAL, INC.

Primary DI Number: B040CPIS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 939872651 *Terms of Use

Device Description: Cardiac & Phrenic Insulator

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWC	Controller, Temperature, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K874927	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7189504-056f-4630-9c85-43b5cf01b255
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 01, 2017