TandemLife
GUDID 00814112020470
TandemLife blood pump kit with oxygenator and accessories
CARDIACASSIST, INC.
Extracorporeal membrane oxygenator| Primary Device ID | 00814112020470 |
| NIH Device Record Key | ef33bdae-275d-49ee-9d54-47fd6fe0e3db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TandemLife |
| Version Model Number | 5740-0000 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814112020470 [Primary] |
FDA Product Code
| DTZ | Oxygenator, Cardiopulmonary Bypass |
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 | 2016-06-23 |
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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