Edwards Lifesciences Vent Catheter E061

GUDID 00690103030891

Vent Catheter

Edwards Lifesciences LLC

Chamber-decompression cardiac catheter

• Primary Device ID: 00690103030891
• NIH Device Record Key: e7fe1566-ba58-4f79-9e99-ea6e5546b267
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards Lifesciences Vent Catheter
• Version Model Number: E061
• Catalog Number: E061
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103030891 [Primary]
GS1	50690103030896 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113411

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

On-Brand Devices [Edwards Lifesciences Vent Catheter]

• 00690103147469: Vent Catheter
• 00690103030907: Vent Catheter
• 00690103030891: Vent Catheter
• 00690103030884: Vent Catheter