| Primary Device ID | 00814112020555 |
| NIH Device Record Key | 6a6f2249-2645-4453-8037-7e8a0a6bd81d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProtekDuo |
| Version Model Number | 5730-3631 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814112020555 [Primary] |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2018-10-08 |
| 00814112020555 | TandemHeart Blood Pump Kit with 31 Fr Mini V-V cannula, TandemLung Oxygentor |
| 00814112020548 | TandemHeart Blood Pump Kit with 31 Fr Mini Veno-Venous Cannula |
| 00814112020531 | 31 Fr x 36 cm Dual Lumen VV Cannula Set |
| 00814112020456 | Four 25 cm Dilators (14 Fr, 18 Fr, 22 Fr, and 26 Fr) |
| 00814112020418 | TandemHeart blood pump kit with 31 Fr veno-venous cannula |
| 00814112020401 | TandemHeart blood pump kit with 29 Fr veno-venous cannula |
| 00814112020319 | 31 Fr x 51 cm Veno-Venous Dual Lumen Cannula with Introducer |