HemoSphere HEMCSM10

GUDID 00690103202762

CLEARSIGHT MODULE

Edwards Lifesciences LLC

General-purpose multi-parameter bedside monitor

• Primary Device ID: 00690103202762
• NIH Device Record Key: 14a97c9b-f059-4bca-adc7-07573b68ac8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoSphere
• Version Model Number: HEMCSM10
• Catalog Number: HEMCSM10
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -18 to 45 °C Relative humidity: 20 to 90% non-condensing at 45 °C Altitude: 0 to 19,685 feet (6,000 m)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103202762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201446

FDA Product Code

• DQK: Computer, Diagnostic, Programmable
• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2021-08-02
• Device Publish Date: 2021-07-23

On-Brand Devices [HemoSphere]

• 00690103199321: Pressure Cable
• 00690103197105: HemoSphere Roll Stand
• 00690103197006: HemoSphere Advanced Monitor
• 00690103196993: HemoSphere Swan-Ganz Module
• 00690103196986: HemoSphere Oximetry Cable
• 00690103199338: DPT OUT CABLE
• 00690103202762: CLEARSIGHT MODULE