AIRFIT N20 63541

GUDID 00619498635412

AIRFIT N20 FRAME SYS - MED

RESMED LIMITED

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00619498635412
• NIH Device Record Key: eb6cfe42-bed6-4f4d-8c8e-888c1cd9d114
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIRFIT N20
• Version Model Number: 63541
• Catalog Number: 63541
• 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	00619498635412 [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 N20]

• 00619498635672: AIRFIT N20 FRAME (FOR HER)
• 00619498635665: AIRFIT N20 FRAME
• 00619498635658: AIRFIT N20 ELBOW AND TUBE
• 00619498635627: AIRFIT N20 HEADGEAR - LGE
• 00619498635610: AIRFIT N20 HEADGEAR - STD
• 00619498635603: AIRFIT N20 HEADGEAR - SML
• 00619498635580: AIRFIT N20 HEADGEAR (FH) - STD
• 00619498635566: AIRFIT N20 FRAME SYS - LGE
• 00619498635559: AIRFIT N20 FRAME SYS - MED
• 00619498635542: AIRFIT N20 FRAME SYS (FH) - SMD
• 00619498635528: AIRFIT N20 CUSHION LGE
• 00619498635511: AIRFIT N20 CUSHION MED
• 00619498635504: AIRFIT N20 CUSHION SML
• 00619498635399: AIRFIT N20 MULTI - LGE
• 00619498635382: AIRFIT N20 MULTI - MED
• 00619498635375: AIRFIT N20 MULTI (FH) -SML
• 00619498635368: AIRFIT N20 MULTI -SML
• 00619498635351: AIRFIT N20 STARTER PK
• 00619498635344: AirFit N20 Starter Pk (For Her)
• 00619498635078: AIRFIT N20 LGE SYS - SLM
• 00619498635061: AIRFIT N20 MED SYS - SLM
• 00619498635054: AIRFIT N20 SML (FOR HER) - SLM
• 00619498635047: AirFit N20 SML SYS - SLM
• 00619498635030: AirFit N20 SML SYS
• 00619498635023: AIRFIT N20 LGE SYS
• 00619498635016: AIRFIT N20 MED SYS
• 00619498635009: AIRFIT N20 SML (FOR HER)
• 00619498002917: AirFit N20 LGE Headgear - SLM
• 00619498002443: AirFit N20 STD Headgear - SLM
• 00619498002900: AirFit N20 SML Headgear - SLM
• 00619498635535: AIRFIT N20 FRAME SYS - SML
• 00619498635481: AIRFIT N20 HEADGEAR - LGE
• 00619498635450: AIRFIT N20 CUSHION LGE
• 00619498635443: AIRFIT N20 CUSHION MED
• 00619498635429: AIRFIT N20 FRAME SYS - LGE
• 00619498635412: AIRFIT N20 FRAME SYS - MED
• 00619498635405: AIRFIT N20 FRAME SYS - SML
• 00619498635474: AIRFIT N20 HEADGEAR - STD