Oxyensure
GUDID 09353645401000
Oxyensure POC
RESMED ASIA PTE. LTD.
Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator| Primary Device ID | 09353645401000 |
| NIH Device Record Key | 4db3c202-367a-44e6-9c45-93930bb04fff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oxyensure |
| Version Model Number | 40100 |
| Company DUNS | 659276906 |
| Company Name | RESMED ASIA PTE. LTD. |
| 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 | true |
| 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
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09353645401000 [Primary] |
FDA Product Code
| CAW | Generator, Oxygen, Portable |
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 | 2020-04-20 |
| Device Publish Date | 2019-02-28 |
Devices Manufactured by RESMED ASIA PTE. LTD.
| 09353645401048 - Oxyensure Mounting Straps | 2023-07-31 Oxyensure POC Mounting Straps (AMO) |
| 09353645350520 - External Battery Assembly | 2023-04-04 Mobi External Battery |
| 09353645000098 - Charger AC/DC with power cord | 2021-07-22 Activox, Charger AC/DC with power cord |
| 09353645350537 - AC/DC Charger US | 2021-07-22 AC/DC Charger US (AMO) |
| 09353645401062 - Oxyensure AC/DC Charger US | 2021-07-22 Oxyensure POC AC/DC Charger US (AMO) |
| 09353645000562 - Mobi | 2021-01-18 Mobi - Refurbished |
| 09353645000104 - Charger DC/DC | 2020-04-20 Activox, Charger DC/DC |
| 09353645350018 - Mobi | 2020-04-20 Mobi AMER1 (AMO) |
Trademark Results [Oxyensure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXYENSURE 88854929 not registered Live/Pending |
Expedite LLC 2020-03-31 |
 OXYENSURE 88621363 not registered Live/Pending |
Expedite LLC 2019-09-18 |
 OXYENSURE 88190390 5780521 Live/Registered |
Expedite LLC 2018-11-12 |
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