AIRCURVE 37383

GUDID 00619498373833

AirCurve 10 VAUTO USA C2C CO

RESMED PTY LTD

Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator Portable electric ventilator

• Primary Device ID: 00619498373833
• NIH Device Record Key: 7916904f-eb63-4226-8873-6a68c0203cee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRCURVE
• Version Model Number: 37383
• Catalog Number: 37383
• 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	00619498373833 [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

On-Brand Devices [AIRCURVE]

• 00619498282241: AIRCURVE 10 ST-A IVAPS
• 00619498373857: AirCurve 10 ST USA C2C CO
• 00619498373840: AirCurve 10 ASV USA C2C CO
• 00619498373833: AirCurve 10 VAUTO USA C2C CO
• 00619498282852: AirCurve 10 ST-A USA C2C CO