Primary Device ID | 00814112020043 |
NIH Device Record Key | 951a76ca-c518-4e02-90cc-96204dd0521a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TandemHeart |
Version Model Number | 2100-0113 |
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 | 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 |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx | |
Phone | +14129637770 |
xxx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814112020043 [Primary] |
KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-10-03 |
Device Publish Date | 2015-10-10 |
00814112020395 | TandemHeart blood pump kit with 72cm venous and 15Fr arterial cannulae |
00814112020388 | TandemHeart blood pump kit with 72cm venous and 17Fr arterial cannulae |
00814112020371 | TandemHeart blood pump kit with 62cm venous and 15Fr arterial cannulae |
00814112020364 | TandemHeart blood pump kit with 62cm venous and 17Fr arterial cannulae |
00814112020265 | TandemHeart Holster, Blood Pump and Oxygenator Securement Accessory |
00814112020180 | TandemHeart wrap, blood pump securement accessory |
00814112020111 | 15 Fr x 17 cm femoral arterial cannula with 10 Fr introducer |
00814112020104 | 17 Fr x 17 cm femoral arterial cannula with 12 Fr Introducer |
00814112020098 | 21 Fr x 72 cm venous cannula with dilator and introducer |
00814112020067 | 21 Fr x 62 cm venous cannula with dilator and introducer |
00814112020050 | TandemHeart blood pump kit with accessories |
00814112020043 | TandemHeart blood pump |
00814112020036 | TandemHeart blood pump kit with venous cannula |
00814112020029 | Infusion tubing (5 pack) |
00814112020012 | TandemHeart holster, blood pump securement accessory |
00814112020005 | Infusion tubing |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TANDEMHEART 76124838 2884588 Live/Registered |
CARDIACASSIST, INC. 2000-09-08 |