| Primary Device ID | 00809708075576 |
| NIH Device Record Key | 30669ad4-6a07-4bb7-95a4-7a6a02f15a16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HOST 2, EPOC, JAPANESE |
| Version Model Number | HH-1009-JP-JP |
| 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 | 00809708075576 [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 |
| 00630414606095 - epoc NXS Host | 2020-07-24 The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequa |
| 00630414606460 - epoc Host2 | 2020-07-23 The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequa |
| 00809708041137 - CAPILLARY TUBE, CARE-FILL, BUNDLE OF 50 | 2018-08-09 |
| 00809708049232 - TUBE, CAPILLARY, VETERINARY, (BUNDLE 50) | 2018-08-09 |
| 00809708114572 - EDM LITE KIT | 2018-05-18 |
| 00809708121860 - EPOC BGEM BUN TEST CARD | 2018-05-18 |
| 00809708150303 - EPOC HOST 2, VETERINARY, CHINA | 2018-05-18 |
| 00809708150310 - EPOC HOST 2, VETERINARY, CHINA, REFURBISHED | 2018-05-18 |