Edwards Lifesciences Aortic Perfusion Cannula AA018C

GUDID 00690103025835

Aortic Perfusion Cannula

Edwards Lifesciences LLC

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

• Primary Device ID: 00690103025835
• NIH Device Record Key: 7bd35a39-6bc9-4a35-979a-b00b651bb1c5
• Commercial Distribution Discontinuation: 2016-11-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Edwards Lifesciences Aortic Perfusion Cannula
• Version Model Number: AA018C
• Catalog Number: AA018C
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103025835 [Primary]
GS1	50690103025830 [Package]; Package: Shipper [10 Units]; Discontinued: 2016-11-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123370

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: 2018-07-06
• Device Publish Date: 2016-08-31

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