| Primary Device ID | B3677010 |
| NIH Device Record Key | 3b1bc7ca-1124-4c80-8a55-14ac2d2d22e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LE BioSleeve |
| Version Model Number | 1 |
| Catalog Number | 70 |
| 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 | B3677010 [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 |
| B3677110 | Cutaneous Electrode Garment |
| B3677010 | Cutaneous Electrode Garment |
| B3676980 | Cutaneous Electrode Garment |
| B3676970 | Cutaneous Electrode Garment |
| B3676800 | Cutaneous Electrode Garment |
| B3676700 | Cutaneous Electrode Garment |
| B3676600 | Cutaneous Electrode Garment |
| B3676500 | Cutaneous Electrode Garment |
| B3676400 | Cutaneous Electrode Garment |