AIR 11 39307

GUDID 00619498393077

AIR11 FILTER, HYPO, 50 PACK

RESMED LIMITED

Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter Heat/moisture exchanger insertable filter

• Primary Device ID: 00619498393077
• NIH Device Record Key: 43fffccc-cd05-4acd-a2db-9427513f59a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIR 11
• Version Model Number: 39307
• Catalog Number: 39307
• 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: 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
• 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
• 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
• 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
• 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
• 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
• 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

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00619498393077 [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: 2021-07-05
• Device Publish Date: 2021-06-25

On-Brand Devices [AIR 11]

• 00619498393015: AIR 11 FILTER, STD 2 PK
• 00619498393008: AIR 11 FILTER STD 1 PK
• 00619498392209: AIR 11 AIR OUTLET
• 00619498392056: AIR 11 PSU 65W USA
• 00619498394203: AIRSENSE 11 AUTOSET USA CO
• 00619498393077: AIR11 FILTER, HYPO, 50 PACK
• 00619498393060: AIR11 FILTER, HYPO, 12 PACK
• 00619498393053: AIR11 FILTER, HYPO, 2 PACK
• 00619498393046: AIR11 FILTER, HYPO, 1 PACK
• 00619498393039: AIR11 FILTER, STD 50 PACK
• 00619498393022: AIR 11 FILTER, STD 12 PK
• 00619498390052: AirSense 11 Elite USA TRI
• 00619498390045: AirSense 11 Elite USA CO
• 00619498390038: AirSense 11 CPAP USA TRI
• 00619498390021: AirSense 11 CPAP USA CO
• 00619498390014: AIRSENSE 11 AUTOSET USA TRI