PROTEK Duo

GUDID 00814112020166

29 Fr x 46 cm veno-venous dual lumen cannula with introducer

CARDIACASSIST, INC.

Mobile extracorporeal gas exchange system catheter kit Mobile extracorporeal gas exchange system catheter kit

• Primary Device ID: 00814112020166
• NIH Device Record Key: 6b7c5b5f-18f4-4ea2-9ff6-64c17143969d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROTEK Duo
• Version Model Number: 5140-4629
• 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: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140999

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 [PROTEK Duo]

• 00814112020173: TandemHeart blood pump kit with veno-venous cannula
• 00814112020166: 29 Fr x 46 cm veno-venous dual lumen cannula with introducer