TandemLife

GUDID 00814112020494

TandemLife Priming Tray Kit: TandemHeart Blood Pump with TandemLung Oxygenator

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: 00814112020494
• NIH Device Record Key: 456708a8-1f31-47f9-afdb-e2a924ea0159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TandemLife
• Version Model Number: 5180-0000
• 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: 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
• 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
• 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
• 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	00814112020494 [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: 4
• Public Version Date: 2020-01-22
• Device Publish Date: 2017-06-07

On-Brand Devices [TandemLife]

• 00814112020524: TandemHeart blood pump,TandemLung Oxygenator,15 Fr Arterial,24 Fr Venous Cannnula and accessorie
• 00814112020517: TandemHeart blood pump,TandemLung Oxygenator,17 Fr Arterial 24 Fr Venous Cannula, and accessorie
• 00814112020500: TandemLife Priming Tray Accessory Kit
• 00814112020494: TandemLife Priming Tray Kit: TandemHeart Blood Pump with TandemLung Oxygenator
• 00814112020470: TandemLife blood pump kit with oxygenator and accessories