AccessGUDID - DEVICE: Adult Heart Cooling Jacket (36641670001314)

GUDID

Device Identifier (DI) Information

Brand Name: Adult Heart Cooling Jacket
Version or Model: 2.4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17-260
Company Name: Cardiomed Supplies Inc

Primary DI Number: 36641670001314
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 18
Labeler D-U-N-S® Number*: 240623124 *Terms of Use

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

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):	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K833112	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: 90125c0d-ea71-4e19-9993-f4b567b7e090
Public Version Date: April 29, 2021
Public Version Number: 1
DI Record Publish Date: April 21, 2021