WRISTECH
GUDID 14719872480164
wrist type blood pressure monitor
HEALTH & LIFE CO., LTD.
Automatic-inflation electronic sphygmomanometer, non-portable| Primary Device ID | 14719872480164 |
| NIH Device Record Key | a05d0869-11f2-41e4-9bf0-2c6cf53e8e72 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WRISTECH |
| Version Model Number | 82-3649 |
| 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 |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 |
| Handling 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 | 04719872480167 [Primary] |
| GS1 | 14719872480164 [Package] Contains: 04719872480167 Package: [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990807
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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-08-11 |
On-Brand Devices [WRISTECH]
| 14719872480188 | wrist type blood pressure monitor |
| 14719872480164 | wrist type blood pressure monitor |
| 14719872480102 | Wrist type blood pressure monitor |
Trademark Results [WRISTECH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WRISTECH 76463392 2813942 Live/Registered |
Telebrands Corp. 2002-10-25 |
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