ResScan 31329

GUDID 00619498313297

RESSCAN V 5.7 CD ASSY

RESMED LIMITED

Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software Ventilator application software

• Primary Device ID: 00619498313297
• NIH Device Record Key: fae9e570-6465-4b6e-859b-5ecf7d44b336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResScan
• Version Model Number: 31329
• Catalog Number: 31329
• Company DUNS: 751149311
• Company Name: RESMED 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: true
• Serial Number: false
• 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: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00619498313297 [Primary]

FDA Product Code

• MNS: Ventilator, Continuous, Non-Life-Supporting

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-13

On-Brand Devices [ResScan]

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• 00619498313327: RESSCAN V 5.9 CD ASSY
• 00619498313303: RESSCAN V 5.8 CD ASSY
• 00619498313297: RESSCAN V 5.7 CD ASSY
• 00619498313273: RESSCAN V 5.5 CD ASSY
• 00619498313020: Patient data management software (web version)
• 00619498229154: RESSCAN DATA CARD MODULE
• 00619498222070: RESSCAN DATA CARD READER
• 00619498222032: RESSCAN USB ADAPTER
• 00619498000722: Patient data management software (web version)
• 00619498313341: RESSCAN V6.0.1 CD ASSY
• 00619498313358: RESSCAN V6.0.2 CD ASSY
• 00619498313365: ResScan V6.1 CD ASSY