OBIX SF1-OBIX

GUDID 05051968042057

OBIX FREEDOM

HUNTLEIGH HEALTHCARE LIMITED

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• Primary Device ID: 05051968042057
• NIH Device Record Key: 525e9d60-94a4-4db6-8633-44958ac56f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OBIX
• Version Model Number: SF1-SL
• Catalog Number: SF1-OBIX
• Company DUNS: 217207083
• Company Name: HUNTLEIGH HEALTHCARE LIMITED
• 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: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk
• Phone: +4402920485885
• Email: sales@huntleigh-diagnostics.co.uk

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Handling Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 0 millibar and 93 millibar
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05051968042057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132650

FDA Product Code

• HGM: System, Monitoring, Perinatal

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: 2020-08-10
• Device Publish Date: 2020-07-31

On-Brand Devices [OBIX]

• 05051968042057: OBIX FREEDOM
• 05051968041234: OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN
• 05051968042071: OBIX ANTEPARTUM-TWIN
• 05051968042972: OBIX INTRAPARTUM/NIBP+SPO2+EMHR+DVI TWINS