Astral 27941

GUDID 00619498279418

Single Limb Valve Adapter

RESMED LIMITED

Portable electric ventilator

• Primary Device ID: 00619498279418
• NIH Device Record Key: 97a5d440-2edd-4198-b1b5-df4c616d3d08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Astral
• Version Model Number: 27941
• Catalog Number: 27941
• 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: 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 Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00619498279418 [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: 2015-12-04

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