Sunbean
GUDID 14719872483295
Upper Arm Blood Pressure Monitor
HEALTH & LIFE CO., LTD.
Automatic-inflation electronic sphygmomanometer, non-portable| Primary Device ID | 14719872483295 |
| NIH Device Record Key | 79f0a2df-4e8c-4987-a986-9e6141bf362c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunbean |
| Version Model Number | HL858A2-LT |
| Company DUNS | 657836743 |
| Company Name | HEALTH & LIFE CO., LTD. |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | true |
Operating and Storage Conditions
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872483298 [Primary] |
| GS1 | 14719872483295 [Package] Contains: 04719872483298 Package: [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190507
FDA Product Code
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
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 | 2021-10-19 |
| Device Publish Date | 2021-10-11 |
Devices Manufactured by HEALTH & LIFE CO., LTD.
| 14719872486043 - ALERTCARE | 2023-08-14 Nebulizer |
| 04719872483380 - PRESTIGE | 2023-06-13 Arm type blood pressure monitor |
| 14719872489198 - Homedics | 2023-02-23 Blood pressure cuff of the blood pressure monitor |
| 14719872489181 - N/A | 2021-12-22 Blood pressure cuff of the blood monitor |
| 14719872483295 - Sunbean | 2021-10-19Upper Arm Blood Pressure Monitor |
| 14719872483295 - Sunbean | 2021-10-19 Upper Arm Blood Pressure Monitor |
| 14719872489167 - Homedics | 2021-10-14 Blood pressure cuff of the blood pressure monitor |
| 14719872489174 - N/A | 2021-10-14 Blood pressure cuff of the blood pressure monitor |
| 14719872483271 - HM01 | 2021-08-10 Arm type blood pressure monitor |
Trademark Results [Sunbean]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUNBEAN 97741369 not registered Live/Pending |
ITC Limited 2023-01-04 |
 SUNBEAN 97741286 not registered Live/Pending |
ITC Limited 2023-01-04 |
 SUNBEAN 90899213 not registered Live/Pending |
Sunbean 2021-08-24 |
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