ForeSight FSESM

GUDID 50690103211332

FORESIGHT MEDIUM SENSOR

Edwards Lifesciences LLC

Tissue saturation oximeter sensor, single-use

• Primary Device ID: 50690103211332
• NIH Device Record Key: 7a811138-d32e-49ff-a6d3-329d7d7fda1e
• 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

Device Dimensions

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Temperature Limitation: -20 ° - 50 °C Humidity Limitation: 15% - 90% RH

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103211337 [Primary]
GS1	50690103211332 [Package]; Contains: 00690103211337; Package: Case [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: 2024-09-03
• Device Publish Date: 2024-08-26

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