Primary Device ID | 09353278000595 |
NIH Device Record Key | aaba2a3b-4702-4a74-b1e5-0ac625d21f62 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kosmos Hub |
Version Model Number | P006966 |
Company DUNS | 080481089 |
Company Name | ECHONOUS, 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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09353278000595 [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 | 2021-11-04 |
Device Publish Date | 2021-10-27 |
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09353278000724 - Kosmos Power Pack (Refurbished) | 2023-03-20 Kosmos Power Pack (Refurbished) |
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09353278000717 - Kosmos OTS iOS Software Package | 2023-03-14 Kosmos OTS iOS Software Package |
09353278000700 - Kosmos OTS Android Doppler Software Package | 2023-02-13 Kosmos OTS Android Doppler Software Package |
09353278000687 - Kosmos OTS Android Linear | 2022-09-14 Kosmos on Android software application for ultrasound imaging |
09353278000694 - Kosmos OTS Android Linear Color | 2022-09-14 Kosmos on Android software application for ultrasound imaging |