EMBOL-X Intra-Aortic Filter with Duraflo Coating EXSSD

GUDID 00690103166347

EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING

Edwards Lifesciences LLC

Embolic protection filtering guidewire Embolic protection filtering guidewire

• Primary Device ID: 00690103166347
• NIH Device Record Key: 36b8124c-3973-4058-8699-c74180934910
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBOL-X Intra-Aortic Filter with Duraflo Coating
• Version Model Number: EXSSD
• Catalog Number: EXSSD
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103166347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062429

FDA Product Code

• DTM: Filter, blood, cardiopulmonary bypass, arterial line

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-08-31

On-Brand Devices [EMBOL-X Intra-Aortic Filter with Duraflo Coating]

• 00690103166378: EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
• 00690103166361: EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
• 00690103166354: EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
• 00690103166347: EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
• 00690103166330: EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING