Edwards Lifesciences Retrograde Cardioplegia Catheter RC014

GUDID 00690103034226

Retrograde Cardioplegia Catheter

Edwards Lifesciences LLC

Coronary sinus cannula

• Primary Device ID: 00690103034226
• NIH Device Record Key: 1faf2819-45bd-4cb1-9f13-4fc318d21a95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards Lifesciences Retrograde Cardioplegia Catheter
• Version Model Number: RC014
• Catalog Number: RC014
• 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	00690103034226 [Primary]
GS1	50690103034221 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123187

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 Retrograde Cardioplegia Catheter]

• 00690103153996: Retrograde Cardioplegia Catheter
• 00690103151725: Retrograde Cardioplegia Catheter
• 00690103151374: Retrograde Cardioplegia Catheter
• 00690103040562: Retrograde Cardioplegia Catheter
• 00690103040555: Retrograde Cardioplegia Catheter
• 00690103038859: Retrograde Cardioplegia Catheter
• 00690103034486: Retrograde Cardioplegia Catheter
• 00690103034479: Retrograde Cardioplegia Catheter
• 00690103034462: Retrograde Cardioplegia Catheter
• 00690103034455: Retrograde Cardioplegia Catheter
• 00690103034448: Retrograde Cardioplegia Catheter
• 00690103034424: Retrograde Cardioplegia Catheter
• 00690103034417: Retrograde Cardioplegia Catheter
• 00690103034400: Retrograde Cardioplegia Catheter
• 00690103034394: Retrograde Cardioplegia Catheter
• 00690103034387: Retrograde Cardioplegia Catheter
• 00690103034370: Retrograde Cardioplegia Catheter
• 00690103034356: Retrograde Cardioplegia Catheter
• 00690103034349: Retrograde Cardioplegia Catheter
• 00690103034332: Retrograde Cardioplegia Catheter
• 00690103034325: Retrograde Cardioplegia Catheter
• 00690103034288: Retrograde Cardioplegia Catheter
• 00690103034271: Retrograde Cardioplegia Catheter
• 00690103034264: Retrograde Cardioplegia Catheter
• 00690103034240: Retrograde Cardioplegia Catheter
• 00690103034233: Retrograde Cardioplegia Catheter
• 00690103034226: Retrograde Cardioplegia Catheter
• 00690103033281: Retrograde Cardioplegia Catheter
• 00690103033007: Retrograde Cardioplegia Catheter
• 00690103032994: Retrograde Cardioplegia Catheter