Hello Heart
GUDID 04719872483496
Arm type blood pressure monitor
HEALTH & LIFE CO., LTD.
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist| Primary Device ID | 04719872483496 |
| NIH Device Record Key | 25853443-af71-485c-aba2-ed34818a9850 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hello Heart |
| Version Model Number | HHBPA-100BT |
| 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 Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719872483496 [Primary] |
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 | 2025-04-28 |
| Device Publish Date | 2025-04-18 |
Devices Manufactured by HEALTH & LIFE CO., LTD.
| 04719872483571 - Homedics | 2025-06-18 Arm type blood pressure monitor |
| 04719872483496 - Hello Heart | 2025-04-28Arm type blood pressure monitor |
| 04719872483496 - Hello Heart | 2025-04-28 Arm type blood pressure monitor |
| 04719872483502 - Homedics | 2025-04-04 Arm type blood pressure monitor |
| 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 | 2021-10-19 Upper Arm Blood Pressure Monitor |
Trademark Results [Hello Heart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HELLO HEART 88777699 not registered Live/Pending |
Hello Heart Inc. 2020-01-29 |
 HELLO HEART 86784510 4972564 Live/Registered |
Hello Doctor, Ltd 2015-10-12 |
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