FORESIGHT ELITE FSEO2004

GUDID 00690103208597

FORESIGHT ELITE OXIMETER PREAMP CABLE, 4M

Edwards Lifesciences LLC

Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable

• Primary Device ID: 00690103208597
• NIH Device Record Key: 791b5065-5c3c-444b-84b6-866ef0fc8148
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORESIGHT ELITE
• Version Model Number: FSEO2004
• Catalog Number: FSEO2004
• 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: 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

Device Dimensions

• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter
• Length: 4 Meter

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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00690103208597 [Primary]

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: 2021-11-18
• Device Publish Date: 2021-11-10

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