PROTEK Duo

GUDID 00814112020173

TandemHeart blood pump kit with 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: 00814112020173
• NIH Device Record Key: 0e369afd-f122-4f30-abeb-f14e3d8c8880
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROTEK Duo
• Version Model Number: 5190-0020
• 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: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx
• Phone: 18003737421
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020173 [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: 3
• 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