AirFit P10

GUDID 00619498629480

CPL AirFit P10 Frame Sys Large

RESMED PTY LTD

CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00619498629480
• NIH Device Record Key: 78926c01-11ed-4b09-be6b-abbafe5ca40d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirFit P10
• Version Model Number: 62948
• 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: true
• RX Perscription: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 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	00619498629480 [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: 2022-06-14
• Device Publish Date: 2022-06-06

On-Brand Devices [AirFit P10]

• 00619498629800: CPL AirFit P10 Mask Sys - Amer
• 00619498629480: CPL AirFit P10 Frame Sys Large
• 00619498629473: CPL AirFit P10 Frame Sys Medium
• 00619498629466: CPL AirFit P10 Frame Sys Small