HEMOSPHERE FORESIGHT MODULE HEMFSM10

GUDID 00690103208573

HEMOSPHERE FORESIGHT MODULE

Edwards Lifesciences LLC

Tissue saturation oximeter

• Primary Device ID: 00690103208573
• NIH Device Record Key: 526b217f-6e33-4415-a890-9bfdd557e86c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEMOSPHERE FORESIGHT MODULE
• Version Model Number: HEMFSM10
• Catalog Number: HEMFSM10
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• 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
• 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
• 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	00690103208573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180003

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: 2020-08-25
• Device Publish Date: 2020-08-17

Devices Manufactured by Edwards Lifesciences LLC

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• 00690103217964 - HemoSphere Alta: 2025-03-21 HemoSphere Alta advanced monitor (Smart Recovery)
• 00690103217971 - HemoSphere Alta: 2025-03-21 HemoSphere Alta monitor (Cardiac)
• 00690103217278 - Edwards: 2025-01-15 Edwards Reusable Plate
• 00690103217292 - Edwards: 2025-01-15 Edwards Reusable Platform
• 00690103218015 - Edwards: 2025-01-15 Edwards Reusable Cradle
• 00690103019063 - HEART VALVE HANDLE ACCESSORY: 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
• 50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS: 2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS