| Primary Device ID | 00814112020531 |
| NIH Device Record Key | 8acff192-e933-480c-bb16-1e5565bcf2ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProtekDuo |
| Version Model Number | 5140-3631 |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +14129637770 |
| gjohnson@tandemlife.com | |
| Phone | +14129637770 |
| gjohnson@tandemlife.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814112020531 [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 | 2018-11-01 |
| Device Publish Date | 2018-10-01 |
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| 00814112020531 | 31 Fr x 36 cm Dual Lumen VV Cannula Set |
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| 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 |