| Primary Device ID | 10858703006303 |
| NIH Device Record Key | af3d1be5-3083-4e98-9745-1e173b46ad48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OmniVersa High Conductivity Electrodes |
| Version Model Number | 26135 |
| Company DUNS | 828331616 |
| Company Name | ACCELERATED CARE PLUS CORP |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 35 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858703006306 [Primary] |
| GS1 | 10858703006303 [Package] Contains: 00858703006306 Package: Inner Pack [4 Units] In Commercial Distribution |
| GS1 | 20858703006300 [Package] Package: Case [10 Units] In Commercial Distribution |
| GS1 | 30858703006307 [Package] Contains: 20858703006300 Package: Display Shipper [10 Units] In Commercial Distribution |
| 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 | 2022-08-01 |
| Device Publish Date | 2022-07-22 |
| 10858703006303 | OmniVersa High Conductivity Electrodes, 2.75 x 5 |
| 10858703006297 | OmniVersa High Conductivity Electrodes, 2 x 4 |
| 10858703006235 | 2" x 2" OmniVersa High Conductivity Electrodes |