| Primary Device ID | B36711002L00 |
| NIH Device Record Key | f414de24-fde1-4d53-ad9a-e9afb5b5a86d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axio 2 Channel Stimulator |
| Version Model Number | 0 |
| Catalog Number | 11002 |
| Company DUNS | 033139835 |
| Company Name | AXIOBIONICS |
| 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 | false |
| 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 |
|---|---|
| HIBCC | B36711002L00 [Primary] |
| IPF | Stimulator, Muscle, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-09-24 |
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| B367145M00 - Spectra 360 Electrode Gel | 2018-10-22 Electrode Gel Monthly Supply (4 8 oz tubes) |