| Primary Device ID | 10840935109990 |
| NIH Device Record Key | c7522274-17d9-4422-8d48-ff0d3ba14213 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Seiva |
| Version Model Number | 99-02533-80 |
| Company DUNS | 148191133 |
| Company Name | SUNTECH MEDICAL, INC. |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1-919-654-2300 |
| UDI_Mail@suntechmed.com | |
| Phone | +1-919-654-2300 |
| UDI_Mail@suntechmed.com | |
| Phone | +1-919-654-2300 |
| UDI_Mail@suntechmed.com | |
| Phone | +1-919-654-2300 |
| UDI_Mail@suntechmed.com | |
| Phone | +1-919-654-2300 |
| UDI_Mail@suntechmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840935109990 [Primary] |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-08 |
| Device Publish Date | 2022-10-31 |
| 10840935110217 - ProLife | 2023-06-19 |
| 10840935110224 - SunTech APC | 2023-06-19 |
| 10840935110231 - ProLife | 2023-06-19 |
| 10840935110248 - ProLife | 2023-06-19 |
| 10840935110255 - ProLife | 2023-06-19 |
| 10840935110262 - ProLife | 2023-06-19 |
| 10840935110279 - SunTech APC | 2023-06-19 |
| 10840935110286 - SunTech APC | 2023-06-19 |