TandemHeart

GUDID 00814112020104

17 Fr x 17 cm femoral arterial cannula with 12 Fr Introducer

CARDIACASSIST, INC.

Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass cannula, femoral Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial
Primary Device ID00814112020104
NIH Device Record Key1312728b-1757-4200-9ae2-a3aa25c0325f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTandemHeart
Version Model Number5130-1717
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 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

Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
Emailxxx@xx.xx
Phone+14129637770
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 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814112020104 [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]

00814112020395TandemHeart blood pump kit with 72cm venous and 15Fr arterial cannulae
00814112020388TandemHeart blood pump kit with 72cm venous and 17Fr arterial cannulae
00814112020371TandemHeart blood pump kit with 62cm venous and 15Fr arterial cannulae
00814112020364TandemHeart blood pump kit with 62cm venous and 17Fr arterial cannulae
00814112020265TandemHeart Holster, Blood Pump and Oxygenator Securement Accessory
00814112020180TandemHeart wrap, blood pump securement accessory
0081411202011115 Fr x 17 cm femoral arterial cannula with 10 Fr introducer
0081411202010417 Fr x 17 cm femoral arterial cannula with 12 Fr Introducer
0081411202009821 Fr x 72 cm venous cannula with dilator and introducer
0081411202006721 Fr x 62 cm venous cannula with dilator and introducer
00814112020050TandemHeart blood pump kit with accessories
00814112020043TandemHeart blood pump
00814112020036TandemHeart blood pump kit with venous cannula
00814112020029Infusion tubing (5 pack)
00814112020012TandemHeart holster, blood pump securement accessory
00814112020005Infusion tubing

Trademark Results [TandemHeart]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TANDEMHEART
TANDEMHEART
76124838 2884588 Live/Registered
CARDIACASSIST, INC.
2000-09-08

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