ResScan 31335

GUDID 00619498313358

RESSCAN V6.0.2 CD ASSY

RESMED LIMITED

Ventilator application software

• Primary Device ID: 00619498313358
• NIH Device Record Key: 6717338a-6665-4a93-87e3-dd426384a4da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResScan
• Version Model Number: 31335
• Catalog Number: 31335
• 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: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com
• Phone: 1.800.424.0737
• Email: reception@resmed.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00619498313358 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-18
• Device Publish Date: 2019-11-08

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