ProtekDuo

GUDID 00814112020319

31 Fr x 51 cm Veno-Venous Dual Lumen Cannula with Introducer

CARDIACASSIST, INC.

Mobile extracorporeal gas exchange system catheter kit

• Primary Device ID: 00814112020319
• NIH Device Record Key: 7530b28f-c988-4c99-905a-79502c8de699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProtekDuo
• Version Model Number: 5140-5131
• 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: 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: 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	00814112020319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160257

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: 2016-09-23

On-Brand Devices [ProtekDuo]

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• 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