Primary Device ID | 00814112020173 |
NIH Device Record Key | 0e369afd-f122-4f30-abeb-f14e3d8c8880 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PROTEK Duo |
Version Model Number | 5190-0020 |
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 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx | |
Phone | 18003737421 |
xxx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814112020173 [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 | 3 |
Public Version Date | 2018-10-03 |
Device Publish Date | 2015-10-10 |
00814112020173 | TandemHeart blood pump kit with veno-venous cannula |
00814112020166 | 29 Fr x 46 cm veno-venous dual lumen cannula with introducer |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PROTEK DUO 86934746 5131790 Live/Registered |
CardiacAssist, Inc. 2016-03-09 |