AirMini 38101
GUDID 00619498381012
AirMini AutoSet B
RESMED LIMITED
Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit Home CPAP unit| Primary Device ID | 00619498381012 |
| NIH Device Record Key | 0f299ee2-4068-4913-abb7-c01aa9438b4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AirMini |
| Version Model Number | 38101 |
| Catalog Number | 38101 |
| Company DUNS | 751149311 |
| Company Name | RESMED LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com | |
| Phone | 800-427-0737 |
| reception@resmed.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 73 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00619498381012 [Primary] |
FDA Product Code
| MNR | Ventilatory Effort Recorder |
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 | 2017-01-09 |
On-Brand Devices [AirMini]
| 00619498388455 | P10 CONNECTOR FOR AIRMINI |
| 00619498388257 | F20 AirMini Setup Pack |
| 00619498388240 | P10 AirMini Mask Pack |
| 00619498388233 | N20 AirMini Setup Pack |
| 00619498388035 | P10 AirMini Mask |
| 00619498388028 | N20 AirMini Setup Pack |
| 00619498388011 | F20 AirMini Setup Pack |
| 00619498381135 | AirMini AutoSet W |
| 00619498381029 | AirMini AutoSet |
| 00619498381012 | AirMini AutoSet B |
| 00619498388448 | N20 CONNECTOR FOR AIRMINI |
| 00619498388431 | F20 CONNECTOR FOR AIRMINI |
| 00619498380107 | F30 AIRMINI SETUP PACK |
| 00619498380114 | F20 AIRMINI SETUP PACK + HUMIDX |
Trademark Results [AirMini]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AIRMINI 79190330 5102639 Live/Registered |
ResMed Pty Ltd 2016-05-11 |
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