VIGILEO MHAND

GUDID 00690103181449

PRESSURE SLAVE CABLE

Edwards Lifesciences LLC

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00690103181449
• NIH Device Record Key: 05bd2433-fb91-4335-83d3-b6a806a93f7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIGILEO
• Version Model Number: MHAND
• Catalog Number: MHAND
• 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: 8 Feet
• Length: 8 Feet

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	00690103181449 [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 [VIGILEO]

• 00690103187267: VIGILEO ANALOG SLAVE CABLE, DATEX DIN7
• 00690103186093: PRESSURE SLAVE CABLE
• 00690103181456: PRESSURE SLAVE CABLE
• 00690103181449: PRESSURE SLAVE CABLE
• 00690103181418: PRESSURE SLAVE CABLE