| Primary Device ID | 04719882150074 |
| NIH Device Record Key | b52e35c7-aab5-404a-8c54-b1baf94a90de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LELTEK |
| Version Model Number | LU710M |
| Company DUNS | 656116467 |
| Company Name | LELTEK 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 | true |
| 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 | 04719882150074 [Primary] |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-03 |
| Device Publish Date | 2022-10-26 |
| 04719882150074 - LELTEK | 2022-11-03 |
| 04719882150074 - LELTEK | 2022-11-03 |
| 04719882152054 - ASUS | 2021-08-19 |
| 04719882152061 - ASUS | 2021-08-19 |
| 04719882150067 - LeSono | 2021-02-04 |
| 04719882151019 - Norland at Swissray | 2021-02-04 |
| 04719882151026 - Norland at Swissray | 2021-02-04 |
| 04719882150043 - LeSono | 2021-01-26 |
| 04719882150050 - LeSono | 2021-01-26 |