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

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• Primary Device ID: 16641670001303
• NIH Device Record Key: 90125c0d-ea71-4e19-9993-f4b567b7e090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult Heart Cooling Jacket
• Version Model Number: 2.4
• Catalog Number: 17-260
• Company DUNS: 240623124
• Company Name: Cardiomed Supplies Inc
• Device Count: 18
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16641670001303 [Unit of Use]
GS1	36641670001314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833112

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-29
• Device Publish Date: 2021-04-21

Devices Manufactured by Cardiomed Supplies Inc

• 16641670001303 - Adult Heart Cooling Jacket: 2021-04-29The 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 Jacket: 2021-04-29 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 Set: 2021-04-29
• 16641670001341 - Pediatric Heart Cooling Jacket: 2021-04-29
• 16641670011517 - rescuCLAMP™ Catheter Repair Clamp: 2021-04-29 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 Holders: 2021-04-29
• 16641670004168 - 3/8'' x 1/4'' x 3/8'' Y Connector: 2020-12-10 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 Connector: 2020-12-10 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 Connector: 2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment