AIRCURVE 28211
GUDID 00619498282111
AIRCURVE 10 ST-A
RESMED LIMITED
Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit Home BPAP unit| Primary Device ID | 00619498282111 |
| NIH Device Record Key | 781b695b-e977-49f5-80d2-9a09d767f221 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIRCURVE |
| Version Model Number | 28211 |
| Catalog Number | 28211 |
| 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 | 00619498282111 [Primary] |
| GS1 | 00619498283262 [Direct Marking] |
FDA Product Code
| MNS | Ventilator, Continuous, Non-Life-Supporting |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-20 |
| Device Publish Date | 2016-09-09 |
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 |
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