konsung
GUDID 06934822565031
The Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in home, institution environments. The device is not intended to sustain or support life. The device is intended for use in adults.
Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.
Stationary oxygen concentrator| Primary Device ID | 06934822565031 |
| NIH Device Record Key | 303adb54-061a-4284-bfdd-33566c8f17e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | konsung |
| Version Model Number | KSOC-5 |
| Company DUNS | 544307339 |
| Company Name | Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06934822565031 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223740
FDA Product Code
| CAW | Generator, Oxygen, Portable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-03 |
| Device Publish Date | 2023-10-26 |
On-Brand Devices [konsung]
| 06934822531296 | This device is a small, lightweight, portable device intended for use in measuring and displayin |
| 06934822531234 | This device is a small, lightweight, portable device intended for use in measuring and displayin |
| 06934822531173 | This device is a small, lightweight, portable device intended for use in measuring and displayin |
| 06934822565031 | The Oxygen Concentrator is intended to be used by patients with respiratory disorders who requir |
| 06934822565024 | The Oxygen Concentrator is intended to be used by patients with respiratory disorders who requir |
| 06934822565017 | The Oxygen Concentrator is intended to be used by patients with respiratory disorders who requir |
Trademark Results [konsung]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KONSUNG 88562467 not registered Live/Pending |
Wang Jingyi 2019-08-02 |
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