| Primary Device ID | 10754756750005 |
| NIH Device Record Key | 48b4369a-9230-4d6b-aa2e-74832c968b09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Essential Digital TENS System |
| Version Model Number | S2000 |
| Company DUNS | 189331325 |
| Company Name | ESSENTIAL MEDICAL SUPPLY 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | 407-770-0710 |
| michael.hoepner@essentialmedicalsupply.com | |
| Phone | 407-770-0710 |
| michael.hoepner@essentialmedicalsupply.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00754756750008 [Primary] |
| GS1 | 10754756750005 [Package] Contains: 00754756750008 Package: [30 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2017-04-11 |
| 10754756740006 - Essential TENS System | 2019-10-23 |
| 20754756740010 - TENS Electrode Set | 2019-10-23 |
| 10754756750005 - Essential Digital TENS System | 2019-10-23 |
| 10754756750005 - Essential Digital TENS System | 2019-10-23 |
| 00754756380007 - Endurance Standard Alternating Pressure Pump | 2018-03-29 |
| 00754756380014 - Endurance Standard Alternating Pressure Pump & Pad Combo | 2018-03-29 |
| 10754756388000 - Endurance Standard Alternating Pressure Bubble Pad | 2018-03-29 |
| 00754756388010 - Endurance Standard Alternating Pressure Bubble Pad w/Flaps | 2018-03-29 |
| 00754756390006 - Endurance Deluxe Alternating Pressure Pump | 2018-03-29 |