| Primary Device ID | B62536084000 |
| NIH Device Record Key | 6891bc5b-7328-4f28-aeb5-15623378ea93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OmniPro System |
| Version Model Number | OmniAmp PSG Module |
| Catalog Number | 360-8400 |
| Company DUNS | 101772069 |
| Company Name | Mays & Asscoiates |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Phone | 615-973-2027 |
| burke.mays@maysinc.net |
| Weight | 675 Gram |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B62536084000 [Primary] |
| OLV | Standard Polysomnograph With Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-17 |
| Device Publish Date | 2019-12-09 |
| B62571884000 | OmniPro PSG System used in PSG physiological data collection |
| B62571883000 | OmniPro EEG System used in EEG physiological data collection |
| B62536084100 | The OmniAmp Interface Module is an amplifier interface module used in polysomnogram (PSG) and el |
| B62536084000 | The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a hospital or diagn |
| B62536083000 | The OmniAmp EEG Module is an amplifier system for use in electroencephalogram (EEG) studies in a |