AIRSENSE 37382

GUDID 00619498373826

AirSense 10 AutoSet NA C2C CO

RESMED PTY LTD

Home CPAP unit

• Primary Device ID: 00619498373826
• NIH Device Record Key: d7992bcd-4a85-4504-aa84-a7df313c238c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRSENSE
• Version Model Number: 37382
• Catalog Number: 37382
• Company DUNS: 751149311
• Company Name: RESMED PTY LTD
• 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: 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: 800-427-0737
• Email: reception@resmed.com
• Phone: 800-427-0737
• Email: reception@resmed.com
• Phone: 800-427-0737
• Email: reception@resmed.com
• Phone: 800-427-0737
• Email: reception@resmed.com
• Phone: 800-427-0737
• Email: reception@resmed.com
• Phone: 800-427-0737
• Email: reception@resmed.com
• Phone: 800-427-0737
• Email: reception@resmed.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00619498373826 [Primary]

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

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: 2022-06-13
• Device Publish Date: 2022-06-03

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