HEART VALVE HANDLE ACCESSORY 1111

GUDID 00690103019063

HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV

Edwards Lifesciences LLC

Heart valve prosthesis holder, reusable

• Primary Device ID: 00690103019063
• NIH Device Record Key: aba2ada6-c410-4462-84b8-54427b840452
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEART VALVE HANDLE ACCESSORY
• Version Model Number: 1111
• Catalog Number: 1111
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103019063 [Primary]

FDA Product Code

• DTJ: Holder, Heart-Valve, Prosthesis

Sterilization

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

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

[00690103019063]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-28
• Device Publish Date: 2024-10-18

Devices Manufactured by Edwards Lifesciences LLC

• 00690103220629 - ESHEATH OPTIMA INTRODUCER SET (14F): 2025-05-15 eSheath Optima Introducer Set (14F)
• 00690103217957 - HemoSphere Alta: 2025-03-21 HemoSphere Alta advanced monitor (All-on-one)
• 00690103217964 - HemoSphere Alta: 2025-03-21 HemoSphere Alta advanced monitor (Smart Recovery)
• 00690103217971 - HemoSphere Alta: 2025-03-21 HemoSphere Alta monitor (Cardiac)
• 00690103217278 - Edwards: 2025-01-15 Edwards Reusable Plate
• 00690103217292 - Edwards: 2025-01-15 Edwards Reusable Platform
• 00690103218015 - Edwards: 2025-01-15 Edwards Reusable Cradle
• 00690103019063 - HEART VALVE HANDLE ACCESSORY: 2024-10-28HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
• 00690103019063 - HEART VALVE HANDLE ACCESSORY: 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV