ProtekDuo

GUDID 00814112020555

TandemHeart Blood Pump Kit with 31 Fr Mini V-V cannula, TandemLung Oxygentor

CARDIACASSIST, INC.

Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set Mechanical infusion pump administration set

• Primary Device ID: 00814112020555
• NIH Device Record Key: 6a6f2249-2645-4453-8037-7e8a0a6bd81d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProtekDuo
• Version Model Number: 5730-3631
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com
• Phone: +14129637770
• Email: gjohnson@tandemlife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020555 [Primary]

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: 2
• Public Version Date: 2020-01-22
• Device Publish Date: 2018-10-08

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