| Primary Device ID | 16945040104480 |
| NIH Device Record Key | 1f8cdfea-80ad-4b37-9c44-28b1d8ba0ac9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Santamedical |
| Version Model Number | SM-165 |
| Company DUNS | 529606295 |
| Company Name | Contec Medical Systems Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06945040104483 [Primary] |
| GS1 | 16945040104480 [Package] Contains: 06945040104483 Package: Carton [200 Units] In Commercial Distribution |
| OCH | Oximeter, Infrared, Sporting, Aviation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-09-01 |
| 06945040110637 - CONTEC | 2025-08-20 Medicinal Nonventilatory Nebulizer(Atomizer) |
| 06945040106197 - CONTEC | 2024-11-19 Automatic Pressure Infusor |
| 06945040109914 - CONTEC | 2024-07-24 Pocket Fetal Doppler |
| 06945040109938 - CONTEC | 2024-07-24 Pocket Fetal Doppler |
| 06945040109952 - CONTEC | 2024-07-24 Pocket Fetal Doppler |
| 06945040106555 - CONTEC | 2024-06-03 B-Ultrasound Diagnostic System |
| 06945040106593 - CONTEC | 2024-06-03 Color Doppler Ultrasound Diagnostic System |
| 06945040106913 - CONTEC | 2024-06-03 Color Doppler Ultrasound Diagnostic System |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SANTAMEDICAL 90527036 not registered Live/Pending |
GURIN PRODUCTS, LLC 2021-02-12 |
![]() SANTAMEDICAL 85521970 4252918 Live/Registered |
Gupta, Sanjay 2012-01-21 |