URIT
GUDID 06935740733755
Urit Medical Electronic Co., Ltd.
Urine analyser IVD, laboratory| Primary Device ID | 06935740733755 |
| NIH Device Record Key | e559e632-f6b8-4c62-8ebd-3c97df82f20f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | URIT |
| Version Model Number | UC-1800 |
| Company DUNS | 653742429 |
| Company Name | Urit Medical Electronic Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 86 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06935740733755 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232317
FDA Product Code
| JFY | Enzymatic Method, Creatinine |
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 | 2024-06-24 |
| Device Publish Date | 2024-06-14 |
Devices Manufactured by Urit Medical Electronic Co., Ltd.
| 06935740726993 - Hemoglobin Test Strip | 2024-09-30 |
| 06935740726986 - Blood Lipid Test Strip | 2024-07-22 |
| 06935740727006 - Uric Acid Test Strip | 2024-07-22 |
| 06935740727013 - Uric Acid Test Strip | 2024-07-22 |
| 06935740727020 - Uric Acid Test Strip | 2024-07-22 |
| 06935740727037 - Uric Acid Test Strip | 2024-07-22 |
| 06935740733830 - Hemoglobin Test Strip | 2024-07-22 |
| 06935740733847 - Hemoglobin Test Strip | 2024-07-22 |
Trademark Results [URIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 URIT 79109955 4378090 Live/Registered |
Urit Medical Electronic Co., Ltd. 2011-07-01 |
 URIT 75800616 2450127 Dead/Cancelled |
Carson Pirie Scott II, Inc. 1999-09-16 |
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