DINAPT

GUDID 00690103194579

UNIVERSAL ADAPTER

Edwards Lifesciences LLC

Pin-indexed adaptor, reusable

• Primary Device ID: 00690103194579
• NIH Device Record Key: fecad068-e811-46d4-a45f-ad005f7da59f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DINAPT
• Catalog Number: DINAPT
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 2
• 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

Device Dimensions

• Outer Diameter: 0.08 Inch
• Outer Diameter: 0.08 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103194579 [Primary]
GS1	70690103194578 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K813521

FDA Product Code

• LDF: ELECTRODE, PACEMAKER, TEMPORARY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-03

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