Arterial Perfusion Cannula APC020

GUDID 00690103026344

Edwards Lifesciences Arterial Perfusion Cannula

Edwards Lifesciences LLC

Cardiopulmonary bypass cannula, arterial

• Primary Device ID: 00690103026344
• NIH Device Record Key: 444567ac-114f-4059-afb9-ca4e815b2e9d
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Arterial Perfusion Cannula
• Version Model Number: APC020
• Catalog Number: APC020
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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
• 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 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103026344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894243

FDA Product Code

• DQR: CANNULA, CATHETER

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

Devices Manufactured by Edwards Lifesciences LLC

• 00690103221312 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 20 mm (Gen 2) (US)
• 00690103221329 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 23 mm (Gen 2) (US)
• 00690103221336 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 26 mm (Gen 2) (US)
• 00690103221343 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system: 2026-02-25 Pulmonic Delivery System - 29 mm (Gen 2) (US)
• 00690103019353 - AORTIC TRUE-SIZE OBTURATOR 19MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019360 - AORTIC TRUE-SIZE OBTURATOR 21MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019377 - AORTIC TRUE-SIZE OBTURATOR 23MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE
• 00690103019384 - AORTIC TRUE-SIZE OBTURATOR 25MM: 2026-02-23 AORTIC TRUE-SIZE OBTURATOR F/USE W/1108 HDLE