AIR 10 37309
GUDID 00619498373093
AIR 10 90W PSU
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 | 00619498373093 |
| NIH Device Record Key | 0cc45270-37f9-461e-a216-b6d1d9a2bd31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIR 10 |
| Version Model Number | 37309 |
| Catalog Number | 37309 |
| 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 | true |
| 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 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com | |
| Phone | 800-424-0737 |
| reception@resmed.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 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 | 00619498373093 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [AIR 10]
| 00619498373444 | AIR 10 PSU 90W |
| 00619498373352 | AIR 10 SIDE COVER GRAY |
| 00619498373109 | AIR 10 AIR OUTLET |
| 00619498373093 | AIR 10 90W PSU |
| 00619498373031 | AIR 10 SIDE COVER CHARCOAL |
| 00619498373024 | AIR 10 OXIMETRY MODULE |
| 00619498373017 | AIR 10 USB MODULE |
| 00619498372973 | DC-DC CONVERTER |
| 00619498373949 | AIR 10 TUBING ELBOW |
Trademark Results [AIR 10]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AIR 10 78860645 3282867 Dead/Cancelled |
MJC ACQUISITION, LLC 2006-04-13 |
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