TandemHeart- TRIS

GUDID 00814112020234

21 Fr x 62 cm venous cannula with dilator and introducer

CARDIACASSIST, INC.

Circulatory assist transseptal cannula
Primary Device ID00814112020234
NIH Device Record Keye8671a6c-7712-4741-a905-32a05ad419ce
Commercial Distribution Discontinuation2015-11-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTandemHeart- TRIS
Version Model Number5140-6221TRIS
Company DUNS948683941
Company NameCARDIACASSIST, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx
Phone14129637770
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020234 [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 Date2015-10-15

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