Thin-Flex Single Stage Venous Drainage Cannula TF028L90

GUDID 00690103041033

THIN-FLEX SINGLE STAGE VENOUS DRAINAGE CANNULA

Edwards Lifesciences LLC

Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous

• Primary Device ID: 00690103041033
• NIH Device Record Key: 9ebf5ca9-1136-4d4f-b2f4-ad8131c7925c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thin-Flex Single Stage Venous Drainage Cannula
• Version Model Number: TF028L90
• Catalog Number: TF028L90
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103041033 [Primary]
GS1	50690103041038 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120072

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: 2019-06-12
• Device Publish Date: 2016-08-31

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