ProtekDuo

GUDID 00814112020401

TandemHeart blood pump kit with 29 Fr veno-venous cannula

CARDIACASSIST, INC.

Cardiopulmonary bypass system mounting unit Cardiopulmonary bypass system mounting unit Cardiopulmonary bypass system mounting unit Cardiopulmonary bypass system mounting unit Cardiopulmonary bypass system mounting unit

• Primary Device ID: 00814112020401
• NIH Device Record Key: aaad5126-c4f2-41b9-bf0c-207c6430a4ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProtekDuo
• Version Model Number: 5720-2916
• 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: gjohnson@tandemlife.com
• Phone: 18003737421
• Email: gjohnson@tandemlife.com
• Phone: 18003737421
• Email: gjohnson@tandemlife.com
• Phone: 18003737421
• Email: gjohnson@tandemlife.com
• Phone: 18003737421
• Email: gjohnson@tandemlife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020401 [Primary]

FDA Product Code

• KRI: Accessory Equipment, 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: 3
• Public Version Date: 2018-10-03
• Device Publish Date: 2016-06-13

On-Brand Devices [ProtekDuo]

• 00814112020555: TandemHeart Blood Pump Kit with 31 Fr Mini V-V cannula, TandemLung Oxygentor
• 00814112020548: TandemHeart Blood Pump Kit with 31 Fr Mini Veno-Venous Cannula
• 00814112020531: 31 Fr x 36 cm Dual Lumen VV Cannula Set
• 00814112020456: Four 25 cm Dilators (14 Fr, 18 Fr, 22 Fr, and 26 Fr)
• 00814112020418: TandemHeart blood pump kit with 31 Fr veno-venous cannula
• 00814112020401: TandemHeart blood pump kit with 29 Fr veno-venous cannula
• 00814112020319: 31 Fr x 51 cm Veno-Venous Dual Lumen Cannula with Introducer