| Primary Device ID | 30816625020016 |
| NIH Device Record Key | 486bafcf-2e9d-4405-93ac-695f3c134a44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BF-2 |
| Version Model Number | TENS |
| Company DUNS | 173358318 |
| Company Name | Bio Medical Innovations |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816625020015 [Primary] |
| GS1 | 10816625020012 [Package] Contains: 00816625020015 Package: Inner Pack [20 Units] In Commercial Distribution |
| GS1 | 30816625020016 [Package] Contains: 10816625020012 Package: Case [4 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-03 |
| 30816625020108 - SS-5 | 2020-02-17 2.0" Round electrode patch in pouch of 4 each electrodes |
| 30816625020016 - BF-2 | 2018-03-292" X 2" Square electrode patch in pouch of 4 each electrodes. |
| 30816625020016 - BF-2 | 2018-03-29 2" X 2" Square electrode patch in pouch of 4 each electrodes. |
| 30816625020023 - BF-3 | 2018-03-29 1.875" X 3.75" Rectangular electrode patch in pouch of 4 each electrodes. |
| 30816625020030 - BF-4 | 2018-03-29 1.25" Round electrode patch in pouch of 4 each electrodes. |
| 30816625020047 - BF-5 | 2018-03-29 2.0" Round electrode patch in pouch of 4 each electrodes. |
| 30816625020054 - BF-6 | 2018-03-29 3.0" Round electrode patch in pouch of 4 each electrodes. |
| 30816625020061 - BF-7 | 2018-03-29 1.25" X 2.25" Oval electrode patch in pouch of 4 each electrodes. |
| 30816625020078 - BF-8 | 2018-03-29 2.0" X4.0" Oval electrode patch in pouch of 4 each electrodes. |