Equivital LifeMonitor

GUDID 05060483830032

HIDALGO LIMITED

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 05060483830032
• NIH Device Record Key: e6e430b8-5830-47de-ac6f-a43825b4feea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equivital LifeMonitor
• Version Model Number: EQ-02-B2-1
• Company DUNS: 896220522
• Company Name: HIDALGO 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: false
• 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: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk
• Phone: +4401954233430
• Email: info@equivital.co.uk

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060483830032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113054

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Equivital LifeMonitor]

• 05060483830100: EQ-EX-B4
• 05060483830094: EQ-EX-B3
• 05060483830087: EQ-02-B4
• 05060483830070: EQ-02-B3
• 05060483830063: EQ-EX-SEM-009
• 05060483830056: EQ-02-SEM-012
• 05060483830049: EQ-EX-B1-1
• 05060483830032: EQ-02-B2-1
• 05060483830025: EQ-02-B1-1
• 05060483830018: EQ-EX-SEM-008
• 05060483830001: EQ-02-SEM-007
• 05060483830131: EQ-02-B6
• 05060483830124: EQ-02-B5
• 05060483830117: EQ-EX-B5