ForeSight FSESM

GUDID 50690103208134

ForeSight Sensor Medium

Edwards Lifesciences LLC

Tissue saturation oximeter sensor, single-use

• Primary Device ID: 50690103208134
• NIH Device Record Key: d9c147d4-3e8e-48c8-aa02-c9906fcd659b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ForeSight
• Version Model Number: FSESM
• Catalog Number: FSESM
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 4 Centimeter
• Length: 4 Centimeter
• Length: 4 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103208139 [Primary]
GS1	50690103208134 [Package]; Contains: 00690103208139; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143675

FDA Product Code

• MUD: Oximeter, Tissue Saturation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-15
• Device Publish Date: 2020-05-07

On-Brand Devices [ForeSight]

• 50690103208141: ForeSight Senor Large
• 50690103208134: ForeSight Sensor Medium
• 50690103208127: ForeSight Small Sensor
• 50690103208110: ForeSight Sensor Non-adhesive Small
• 50690103211332: FORESIGHT MEDIUM SENSOR
• 50690103211325: FORESIGHT SMALL SENSOR
• 50690103211318: FORESIGHT NON-ADHESIVE SMALL SENSOR