TandemHeart- TRIS

GUDID 00814112020234

21 Fr x 62 cm venous cannula with dilator and introducer

CARDIACASSIST, INC.

Circulatory assist transseptal cannula

Primary Device ID	00814112020234
NIH Device Record Key	e8671a6c-7712-4741-a905-32a05ad419ce
Commercial Distribution Discontinuation	2015-11-13
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	TandemHeart- TRIS
Version Model Number	5140-6221TRIS
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	true
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
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

Customer Support Contacts

Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx
Phone	14129637770
Email	xxx@xx.xx

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K052570

FDA Product Code

DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-10-03
Device Publish Date	2015-10-15

Devices Manufactured by CARDIACASSIST, INC.

00814112020623 - LifeSPARC	2024-12-11 Blood pump controller
00814112020630 - LifeSPARC	2024-12-11 Charging station for blood pump controller
00814112020678 - LifeSPARC	2024-08-15 LifeSPARC holster, blood pump and oxygenator securement accessory
00814112020586 - LifeSPARC	2023-03-06 Controller Battery
00814112020692 - TandemLife LifeSPARC	2022-08-05 LifeSPARC Blood Pump, TandemLung Oxygenator, 17 Fr Arterial Cannula, 24 Fr Venous Cannula, and accessories
00814112020708 - TandemLife LifeSPARC	2022-08-05 LifeSPARC Blood Pump, TandemLung Oxygenator, 15 Fr Arterial Cannula, 24 Fr Venous Cannnula and accessories
00814112020906 - LifeSPARC	2022-05-18 IV Pole Clamp for blood pump controller
00814112020609 - LifeSPARC	2020-06-08 LifeSPARC Priming Tray Kit: LIfeSPARC Blood Pump with TandemLung Oxygenator