TandemHeart-TRIS

GUDID 00814112020128

TandemHeart blood pump kit with venous cannula (TRIS trial)

CARDIACASSIST, INC.

Cardiopulmonary bypass system centrifugal pump

• Primary Device ID: 00814112020128
• NIH Device Record Key: 275157a2-13c2-46fd-8a5c-0aa4d50b6aeb
• Commercial Distribution Discontinuation: 2015-11-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TandemHeart-TRIS
• Version Model Number: 5190-0015TRIS
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020128 [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: 2015-10-10

On-Brand Devices [TandemHeart-TRIS]

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