HEMOSPHERE HEMPSC100

GUDID 00690103199321

Pressure Cable

Edwards Lifesciences LLC

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00690103199321
• NIH Device Record Key: 86cedacf-5448-4cc7-919c-dee00b0500ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEMOSPHERE
• Version Model Number: HEMPSC100
• Catalog Number: HEMPSC100
• 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

Device Dimensions

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103199321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180881

FDA Product Code

• QAQ: Adjunctive Predictive Cardiovascular Indicator

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: 2019-01-04

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