| Primary Device ID | 00814112020548 |
| NIH Device Record Key | 41d84c70-8d87-498f-b82b-b2e5ac642b37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProtekDuo |
| Version Model Number | 5720-3631 |
| 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 | 00814112020548 [Primary] |
| DRE | Dilator, Vessel, For Percutaneous Catheterization |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-08 |
| 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 |