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 |