TandemHeart-TRIS

GUDID 00814112020128

TandemHeart blood pump kit with venous cannula (TRIS trial)

CARDIACASSIST, INC.

Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump Cardiopulmonary bypass system centrifugal pump
Primary Device ID00814112020128
NIH Device Record Key275157a2-13c2-46fd-8a5c-0aa4d50b6aeb
Commercial Distribution Discontinuation2015-11-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTandemHeart-TRIS
Version Model Number5190-0015TRIS
Company DUNS948683941
Company NameCARDIACASSIST, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18003737421
Emailxxx@xx.xx
Phone18003737421
Emailxxx@xx.xx
Phone18003737421
Emailxxx@xx.xx
Phone18003737421
Emailxxx@xx.xx
Phone18003737421
Emailxxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-03
Device Publish Date2015-10-10

On-Brand Devices [TandemHeart-TRIS]

00814112020135TandemHeart blood pump kit with accessories (TRIS trial)
00814112020128TandemHeart blood pump kit with venous cannula (TRIS trial)

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