| Primary Device ID | B367100M00 |
| NIH Device Record Key | ee5c41bb-ff42-459a-a05c-5f5919f06883 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adhesive Electrode |
| Version Model Number | 0 |
| Catalog Number | 100M |
| 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 | true |
| Serial Number | false |
| 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 | B367100M00 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| B3673350 - UE BioSleeve | 2021-01-18 Cutaneous Electrode Garment Released as revision 5 on 2017-11-28 |
| B36711001L00 - EMPI Focus 2 Channel Stimulator | 2019-10-23 Neuromuscular Stimulator |
| B36711002L00 - Axio 2 Channel Stimulator | 2019-10-23 Neuromuscular Stimulator |
| B3671100300 - Axio 4 Channel Stimulator | 2019-10-23 Neuromuscular Stimulator |
| B36711008L00 - EMPI 300PV Stimulator | 2019-10-23 Neuromuscular Stimulator |
| B36711402L00 - EMPI Continuum | 2019-10-23 Neuromuscular Stimulator |
| B36712159L00 - OOFS Pace XL Stimulator | 2019-10-23 Neuromuscular Stimulator |
| B367145M00 - Spectra 360 Electrode Gel | 2018-10-22 Electrode Gel Monthly Supply (4 8 oz tubes) |