Primary Device ID | 08056446900000 |
NIH Device Record Key | 52393435-08c6-4081-8309-c78fad485100 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BE Micro |
Version Model Number | B9800073000 |
Company DUNS | 339182263 |
Company Name | EB NEURO SPA |
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 | 08056446900000 [Primary] |
DQA | Oximeter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2019-04-01 |
08056446900642 - Galileo NT Line Software | 2020-06-02 Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. |
08056446900154 - Battery Charger | 2020-02-06 Battery Charger for Battery Pack |
08056446900017 - BE Micro Recorder | 2019-11-08 EEG Long Term-Abulatory Recorder |
08056446900024 - BE Micro USB BRIDGE | 2019-11-08 USB interface for EEG ambulatory recorder |
08056446900048 - BE Micro PLUG-IN HEADBOX | 2019-11-08 Patient-interface for EEG ambulatory recorder |
08056446900055 - BE Micro Headbox | 2019-11-08 Patient-interface for EEG ambulatory recorder |
08056446900949 - BE Micro 21 CH MONO PLUG-IN HEADBOX | 2019-11-08 Patient-interface for EEG ambulatory recorder |
08056446900956 - BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL | 2019-11-08 Patient-interface for EEG ambulatory recorder |