Edwards EVOQUE Loading System 9850LSAUS

GUDID 00690103217773

Edwards EVOQUE Loading System

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00690103217773
• NIH Device Record Key: 8879d689-d00d-4952-bb57-8240754c48a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edwards EVOQUE Loading System
• Version Model Number: 9850LSAUS
• Catalog Number: 9850LSAUS
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103217773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230013

FDA Product Code

• NPW: Percutaneously Delivered Prostheses And Tricuspid Valves

Sterilization

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

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

[00690103217773]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-11
• Device Publish Date: 2024-10-03

Devices Manufactured by Edwards Lifesciences LLC

• 00690103217773 - Edwards EVOQUE Loading System: 2024-10-11Edwards EVOQUE Loading System
• 00690103217773 - Edwards EVOQUE Loading System: 2024-10-11 Edwards EVOQUE Loading System
• 00690103219074 - Edwards EVOQUE Valve: 2024-10-11 Edwards EVOQUE Valve, 56mm
• 00690103201079 - Acumen IQ: 2024-10-01 ACUMEN IQ SENSOR 60" / 152CM
• 57460691924845 - TRUWAVE X 3 (3 CC) /VAMP 75 IN (190 CM): 2024-09-12 PRESSURE MONITORING SET
• 57460691924951 - TRUWAVE, VAMP JR: 2024-09-12 PRESSURE MONITORING SET
• 57460691947226 - TRUWAVE, VAMP: 2024-09-12 PRESSURE MONITORING SET
• 57460691947240 - TRUWAVE, VAMP: 2024-09-12 PRESSURE MONITORING SET
• 57460691947462 - TRUWAVE, VAMP: 2024-09-12 PRESSURE MONITORING SET