Edwards Reusable Rail Extension 10500EX

GUDID 00690103219494

Edwards Reusable Rail Extension

Edwards Lifesciences LLC

Cardiac implantation catheter holder, reusable

• Primary Device ID: 00690103219494
• NIH Device Record Key: e6bb7256-d32f-476e-8ee3-431c4d976957
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards Reusable Rail Extension
• Version Model Number: 10500EX
• Catalog Number: 10500EX
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: true
• 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: 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

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
• 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
• 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
• 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
• 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
• 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	00690103219494 [Primary]

FDA Product Code

• QWA: Cardiovascular Delivery Catheter System Positioning And Stabilization Device

Sterilization

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

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

[00690103219494]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-17
• Device Publish Date: 2025-07-09

Devices Manufactured by Edwards Lifesciences LLC

• 50690103205768 - Acumen IQ Sensor with Fluid Meter: 2025-07-18 ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER 5-PACK
• 50690103205782 - ACUMEN IQ: 2025-07-18 ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP 5-PACK
• 00690103205817 - Acumen IQ Fluid Meter: 2025-07-18 Acumen IQ Fluid Meter
• 50690103205829 - ACUMEN IQ: 2025-07-18 Acumen IQ Fluid Meter
• 50690103205836 - Acumen IQ Sensor with Vamp with TruWave: 2025-07-18 ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK
• 00690103219494 - Edwards Reusable Rail Extension: 2025-07-17Edwards Reusable Rail Extension
• 00690103219494 - Edwards Reusable Rail Extension: 2025-07-17 Edwards Reusable Rail Extension
• 00690103219500 - Edwards Reusable Rail: 2025-07-17 Edwards Reusable Rail
• 00690103219562 - Edwards EVOQUE Loading System: 2025-07-17 Edwards EVOQUE Loading System