Adult Heart Cooling Jacket 17-260

GUDID 16641670001303

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.

Cardiomed Supplies Inc

Cardiac arrest hypothermia kit
Primary Device ID16641670001303
NIH Device Record Key90125c0d-ea71-4e19-9993-f4b567b7e090
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Heart Cooling Jacket
Version Model Number2.4
Catalog Number17-260
Company DUNS240623124
Company NameCardiomed Supplies Inc
Device Count18
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116641670001303 [Unit of Use]
GS136641670001314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-29
Device Publish Date2021-04-21

Devices Manufactured by Cardiomed Supplies Inc

16641670001303 - Adult Heart Cooling Jacket2021-04-29The 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.
16641670001303 - Adult Heart Cooling Jacket2021-04-29 The Heart Cooling Jacket is effective in controlling the temperature of the cardiac organ during an open heart surgery. The clos
16641670001327 - Adult Heart Cooling Jacket Recirculation Set2021-04-29
16641670001341 - Pediatric Heart Cooling Jacket2021-04-29
16641670011517 - rescuCLAMP™ Catheter Repair Clamp2021-04-29 The Catheter Repair Clamp is designed with additional openings along the side and the top of the clamp to be quickly added or re
16641670019230 - Drop-It™ Quick Release Needle Holders2021-04-29
16641670004168 - 3/8'' x 1/4'' x 3/8'' Y Connector2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment
16641670004182 - 1/2'' x 3/8'' x 3/8'' Y Connector2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment
16641670004205 - 3/8'' x 1/4'' x 1/4'' Y Connector2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.