Astral 19620

GUDID 00619498196203

INTERNAL BATTERY- ASTRAL

RESMED LIMITED

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

• Primary Device ID: 00619498196203
• NIH Device Record Key: 7642c1a7-b7fd-4fe5-b8d4-99e96ef938ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Astral
• Version Model Number: 19620
• Catalog Number: 19620
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com
• Phone: 800-424-0737
• Email: reception@resmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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 Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• 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	00619498196203 [Primary]

FDA Product Code

• NOU: Continuous, Ventilator, Home Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-26

On-Brand Devices [Astral]

• 00619498279494: Astral Slimfit Mobility Bag
• 00619498279432: Power Supply Unit
• 00619498279425: Single Limb Leak Adapter
• 00619498279418: Single Limb Valve Adapter
• 00619498279401: Double Limb Adapter
• 00619498279395: Inlet Filter Pack
• 00619498279371: Press Sens Filter x40
• 00619498279364: Expiratory Flow Sensor
• 00619498279265: SWITCH AND ALARM CABLE
• 00619498279197: ASTRAL EXTERNAL BATTERY
• 00619498279173: Mobility Bag
• 00619498279159: ASTRAL TABLE STAND
• 00619498270033: Portable ventilator
• 00619498270019: Portable ventilator
• 00619498213566: ASTRAL ACCESSORIES SAMPLE KIT
• 00619498199488: Software Upgrade Kit
• 00619498196203: INTERNAL BATTERY- ASTRAL