AIRFIT F20 63441

GUDID 00619498634415

AIRFIT F20 FRAME SYS MED

RESMED LIMITED

CPAP/BPAP face mask, reusable

• Primary Device ID: 00619498634415
• NIH Device Record Key: a0418cd8-eeed-4203-aab8-905c47f8bbfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRFIT F20
• Version Model Number: 63441
• Catalog Number: 63441
• 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: true
• 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

Operating and Storage Conditions

• 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
• 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
• 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	00619498634415 [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: 2020-07-02
• Device Publish Date: 2020-06-24

On-Brand Devices [AIRFIT F20]

• 00619498634767: AirFit F20 Elbow
• 00619498634750: AirFit F20 Headgear Clip
• 00619498634736: AIRFIT F20 FOR HER HEADGEAR STD
• 00619498634729: AIRFIT F20 HEADGEAR LGE
• 00619498634712: AIRFIT F20 HEADGEAR STD
• 00619498634705: AIRFIT F20 HEADGEAR SML
• 00619498634699: AIRFIT F20 CUSHION LGE
• 00619498634682: AIRFIT F20 CUSHION MED
• 00619498634675: AIRFIT F20 CUSHION SML
• 00619498634668: AIRFIT F20 FOR HER FRAME
• 00619498634651: AIRFIT F20 FRAME
• 00619498634644: AIRFIT F20 FOR HER FRAME SYS MED
• 00619498634637: AIRFIT F20 FOR HER FRAME SYS SML
• 00619498634620: AIRFIT F20 FRAME SYS LGE
• 00619498634613: AIRFIT F20 FRAME SYS MED
• 00619498634606: AIRFIT F20 FRAME SYS SML
• 00619498634569: AIRFIT F20 FOR HER STARTER PACK
• 00619498634507: AIRFIT F20 STARTER PACK
• 00619498634491: AIRFIT F20 FOR HER MED - SLM
• 00619498634484: AIRFIT F20 FOR HER SML - SLM
• 00619498634477: AIRFIT F20 LGE SYS - SLM
• 00619498634460: AIRFIT F20 MED SYS - SLM
• 00619498634453: AIRFIT F20 SML SYS - SLM
• 00619498634040: AIRFIT F20 FOR HER MED
• 00619498634033: AIRFIT F20 FOR HER SML
• 00619498634026: AIRFIT F20 LGE
• 00619498634019: AIRFIT F20 MED
• 00619498634002: AIRFIT F20 SML
• 00619498002986: AIRFIT F20 LGE HEADGEAR - SLM
• 00619498002429: AIRFIT F20 STD HEADGEAR - SLM
• 00619498002979: AIRFIT F20 SML HEADGEAR - SLM
• 00619498634941: F20 QUIETAIR ELBOW
• 00619498634590: AIRFIT F20 CUSHION LGE
• 00619498634583: AIRFIT F20 CUSHION MED
• 00619498634576: AIRFIT F20 CUSHION SML
• 00619498634422: AIRFIT F20 FRAME SYS LGE
• 00619498634415: AIRFIT F20 FRAME SYS MED
• 00619498634408: AIRFIT F20 FRAME SYS SML
• 00619498634972: AIRFIT F20 HEADGEAR LGE
• 00619498634965: AIRFIT F20 HEADGEAR STD
• 00619498634958: AIRFIT F20 HEADGEAR SML