| Primary Device ID | B424400101 |
| NIH Device Record Key | 19a8730d-4ac9-4082-96da-a20466121ad6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colonic Lavage System |
| Version Model Number | PPC-101 Clinical |
| Catalog Number | 400101 |
| Company DUNS | 942667882 |
| Company Name | CLEARWATER COLON HYDROTHERAPY, 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 352-401-0303 |
| sales@colonhydrotherapy.com | |
| Phone | 352-401-0303 |
| sales@colonhydrotherapy.com |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in Room Temperature |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B424400101 [Package] Contains: B4244001010 Package: Wood Crate [1 Units] In Commercial Distribution |
| HIBCC | B4244001010 [Primary] |
| 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 | 2016-09-24 |
| B424400200 | PPC-101 The Traveler UV (Built In Ultra-Violet with 4 filter system) With Carrying Case CCH Part |
| B424400151 | PPC-101 Clinical Model/U.V. Filter System (Specimen Collector) CCH Part No. 400151 |
| B424400101 | PPC-101 Clinical Model/U.V. Filter System CCH Part No. 400101 |