AIRSENSE 37382

GUDID 00619498373826

AirSense 10 AutoSet NA C2C CO

RESMED PTY LTD

Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit 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

Devices Manufactured by RESMED PTY LTD

• 00619498247066 - RPSII-V2 Air10 PSU Adaptor: 2024-03-21 RPSII-V2 Air10 PSU Adaptor
• 00619498247028 - ResMed: 2024-02-27 ResMed Power Station II-V2
• 00619498247059 - ResMed: 2024-02-27 ResMed Power Station II-V2 Battery Pack- Americas
• 00619498646005 - AIRFIT F40: 2024-02-01 AIRFIT F40 SYS - SW/STD AMER
• 00619498646012 - AIRFIT F40: 2024-02-01 AIRFIT F40 SYS - M/STD AMER
• 00619498646029 - AIRFIT F40: 2024-02-01 AIRFIT F40 SYS - L/STD AMER
• 00619498646036 - AIRFIT F40: 2024-02-01 AIRFIT F40 SYS - M/SML AMER
• 00619498646043 - AIRFIT F40: 2024-02-01 AIRFIT F40 SYS - M/LGE AMER