AIRCURVE 37307
GUDID 00619498373079
AIRCURVE 10 ST USA TRI
RESMED LIMITED
Portable electric ventilator| Primary Device ID | 00619498373079 |
| NIH Device Record Key | a5352f46-891e-48da-a72f-fb1ee406c892 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIRCURVE |
| Version Model Number | 37307 |
| Catalog Number | 37307 |
| 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 | true |
| 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 | 00619498370566 [Direct Marking] |
| GS1 | 00619498373079 [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 | 3 |
| Public Version Date | 2018-09-20 |
| Device Publish Date | 2016-09-06 |
On-Brand Devices [AIRCURVE]
| 00619498373079 | AIRCURVE 10 ST USA TRI |
| 00619498373062 | AIRCURVE 10 ST USA CO |
| 00619498372164 | AIRCURVE 10 ASV USA TRI |
| 00619498372157 | AIRCURVE 10 ASV USA CO |
| 00619498372140 | AIRCURVE 10 S USA TRI |
| 00619498372133 | AirCurve 10 S USA CO |
| 00619498372126 | AIRCURVE 10 VAUTO |
| 00619498372119 | AIRCURVE 10 VAUTO |
| 00619498282111 | AIRCURVE 10 ST-A |
| 00619498282104 | AIRCURVE 10 ST-A |
| 00619498374120 | AirCurve 10 ST |
| 00619498374106 | AirCurve 10 ASV |
| 00619498374083 | AirCurve 10 S |
| 00619498374069 | AirCurve 10 VAuto |
Trademark Results [AIRCURVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AIRCURVE 86004235 4700597 Live/Registered |
ResMed Limited 2013-07-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.