| Primary Device ID | B482HC2000C1 |
| NIH Device Record Key | 3f1f6616-9fea-4c0b-a6f0-4ceaa00aa496 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colonic Lavage Unit |
| Version Model Number | HC-2000 Classic |
| Catalog Number | HC-2000 Classic |
| Company DUNS | 562820084 |
| Company Name | TRANSCENDENCIAS COMERCIALES SL |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
|---|---|
| HIBCC | B482HC2000C0 [Primary] |
| HIBCC | B482HC2000C1 [Package] Contains: B482HC2000C0 Package: Box [1 Units] In Commercial Distribution |
| KPL | Colonic Irrigation System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-29 |
| B482HC2000C1 | Colonic Hydroteraphy machine designed for semi-automatic irrigation, washing, and evacuation of |
| B482HC1C1 | Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris f |
| B482HC11 | Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris f |