| Primary Device ID | 00852670007083 |
| NIH Device Record Key | c082e439-58e7-484b-813d-ad1e7889b311 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zynex Medical Electrodes |
| Version Model Number | 300038 |
| Company DUNS | 141582226 |
| Company Name | ZYNEX MEDICAL, INC. |
| 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 | true |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852670007083 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-01 |
| Device Publish Date | 2018-10-01 |
| 00852670007113 | Belt-Electrode Garment, Small/Medium |
| 00852670007106 | Belt-Electrode Garment, Large/Extra Large |
| 00852670007090 | Electrodes, 2” Square for LBG, 4pk |
| 00852670007083 | NM900, Electrodes, 2" Round, 1 set of 3 electrodes. |
| 00852670007076 | Electrode 2” Round , 4 per Package |