Edwards eSheath+ Introducer set 916EPSA

GUDID 00690103215472

Edwards eSheath+ Introducer set

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00690103215472
• NIH Device Record Key: 229da540-2920-43bc-8b65-8e79036eb08d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards eSheath+ Introducer set
• Version Model Number: 916EPSA
• Catalog Number: 916EPSA
• 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
• 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
• 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
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• 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 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Sore in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103215472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200258

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-14
• Device Publish Date: 2021-10-06

On-Brand Devices [Edwards eSheath+ Introducer set ]

• 00690103215472: Edwards eSheath+ Introducer set
• 00690103215465: Edwards eSheath+ Introducer set