| Primary Device ID | 09353278000656 |
| NIH Device Record Key | 6b911031-45ef-4e11-9315-f7a0fadda42a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kosmos UP |
| Version Model Number | P006598 |
| Company DUNS | 080481089 |
| Company Name | ECHONOUS, INC. |
| 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 | true |
| 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 | 09353278000656 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-16 |
| Device Publish Date | 2022-02-08 |
| 09353278000830 - Kosmos | 2025-08-18 MENDAERA 210-00161: PACKAGED TORSO-ONE USB PROBE |
| 09353278000847 - Kosmos | 2025-08-18 MENDAERA 210-00160: PACKAGED LINEAR LEXSA PROBE |
| 09353278000823 - Kosmos OTS iOS | 2025-03-03 Kosmos Application loaded on an iPad. |
| 09353278000854 - Kosmos Link | 2025-03-03 Kosmos Link |
| 09353278000762 - Kosmos OTS iOS | 2024-05-14 KOSMOS OTS iOS SOFTWARE PACKAGE [2.X] |
| 09353278000632 - Kosmos Power Pack | 2023-03-20 Kosmos Power Pack |
| 09353278000724 - Kosmos Power Pack (Refurbished) | 2023-03-20 Kosmos Power Pack (Refurbished) |
| 09353278000663 - EchoNous Samsung S8 Tablet with Software | 2023-03-16 EchoNous (Uscan) Samsung S8 Tablet with Software |