FLOTRAC, VIGILEO APCO9X2

GUDID 00690103184976

CONNECTING CABLE APCO9X2

Edwards Lifesciences LLC

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00690103184976
• NIH Device Record Key: c5fe117d-c071-421e-9493-f0d32448a6f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOTRAC, VIGILEO
• Version Model Number: APCO9X2
• Catalog Number: APCO9X2
• 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: false
• 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

• Length: 216 Inch
• Length: 216 Inch

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103184976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131588

FDA Product Code

• DXG: COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-03

On-Brand Devices [FLOTRAC, VIGILEO]

• 00690103184976: CONNECTING CABLE APCO9X2
• 00690103165418: CONNECTING CABLE APCO9