TandemLife
GUDID 00814112020524
TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnula and accessories
CARDIACASSIST, INC.
Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous| Primary Device ID | 00814112020524 |
| NIH Device Record Key | 45299570-7f10-429c-a803-72a6b6270467 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TandemLife |
| Version Model Number | 5740-2415 |
| Company DUNS | 948683941 |
| Company Name | CARDIACASSIST, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814112020524 [Primary] |
FDA Product Code
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2017-06-21 |
On-Brand Devices [TandemLife]
| 00814112020524 | TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnula and accessorie |
| 00814112020517 | TandemHeart blood pump,TandemLung Oxygenator,17 Fr Arterial 24 Fr Venous Cannula, and accessorie |
| 00814112020500 | TandemLife Priming Tray Accessory Kit |
| 00814112020494 | TandemLife Priming Tray Kit: TandemHeart Blood Pump with TandemLung Oxygenator |
| 00814112020470 | TandemLife blood pump kit with oxygenator and accessories |
Trademark Results [TandemLife]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TANDEMLIFE 86417701 5064789 Live/Registered |
CardiacAssist, Inc. 2014-10-08 |
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