| Primary Device ID | 16641670001327 |
| NIH Device Record Key | edba38df-3e4c-4940-a63a-43916f8ddbe5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adult Heart Cooling Jacket Recirculation Set |
| Version Model Number | 1.4 |
| Catalog Number | 17-260TG |
| Company DUNS | 240623124 |
| Company Name | Cardiomed Supplies Inc |
| Device Count | 2 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 16641670001327 [Unit of Use] |
| GS1 | 36641670001338 [Primary] |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-29 |
| Device Publish Date | 2021-04-21 |
| 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 |
| 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 |