| Primary Device ID | 00814112020401 | 
| NIH Device Record Key | aaad5126-c4f2-41b9-bf0c-207c6430a4ba | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | ProtekDuo | 
| Version Model Number | 5720-2916 | 
| 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 | 
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | |
| Phone | 18003737421 | 
| gjohnson@tandemlife.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00814112020401 [Primary] | 
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2018-10-03 | 
| Device Publish Date | 2016-06-13 | 
| 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 |