HemoSphere Tissue Oximetry Module HEMTOM10

GUDID 00690103200355

HemoSphere Tissue Oximetry Module

Edwards Lifesciences LLC

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 00690103200355
• NIH Device Record Key: b924559c-1305-4476-a0d3-161f7e5e70be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoSphere Tissue Oximetry Module
• Version Model Number: HEMTOM10
• Catalog Number: HEMTOM10
• 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
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• Phone: +1(800)822-9637
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• Phone: +1(800)822-9637
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• Phone: +1(800)822-9637
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• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
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• Phone: +1(800)822-9637
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 C Humidity: 20 to 90% non-condensing at 45 C Altitude: 0 to 20,000 feet (6096 m)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103200355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190205

FDA Product Code

• MUD: Oximeter, Tissue Saturation

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: 2020-02-06
• Device Publish Date: 2019-09-12

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