EMBOL-X Glide Access Device/Aortic Cannula with Flange EXGF24D

GUDID 00690103170269

EMBOL-X GLIDE ACCESS DEVICE / AORTIC CANNULA WITH FLANGE

Edwards Lifesciences LLC

Cardiopulmonary bypass cannula, arterial

• Primary Device ID: 00690103170269
• NIH Device Record Key: 89ef390a-4f65-429f-b179-a06d07721dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBOL-X Glide Access Device/Aortic Cannula with Flange
• Version Model Number: EXGF24D
• Catalog Number: EXGF24D
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry, dark place until ready for use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103170269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102420

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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• 00690103019063 - HEART VALVE HANDLE ACCESSORY: 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
• 50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS: 2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS
• 00690103019339 - HEART VALVE ACCESSOR: 2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
• 00690103166989 - HEART VALVE ACCESSOR: 2024-10-28 MITRAL SIZER HANDLE
• 00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46: 2024-10-28 RING HANDLE - EXTENDED 4"