| Primary Device ID | 00809708049393 |
| NIH Device Record Key | b26addfb-4962-4175-b1f0-24c39460e175 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EPOC HOST, RX, INT'L |
| Version Model Number | HH-0005-XU-00 |
| Company DUNS | 201179681 |
| Company Name | Epocal 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00809708049393 [Primary] |
| CEM | Electrode, Ion Specific, Potassium |
| 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 | 2016-07-05 |