Duns Number:562820084
Device Description: Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Specul Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
Catalog Number
Z-09
Brand Name
Colonic Irrigation Kit
Version/Model Number
Large Hydrokit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131852,K131852,K131852
Product Code
KPL
Product Code Name
Colonic Irrigation System
Public Device Record Key
fd9fed38-a1e7-4550-b7a0-b8ab953d16b6
Public Version Date
September 05, 2022
Public Version Number
6
DI Record Publish Date
December 29, 2016
Package DI Number
B482Z091
Quantity per Package
75
Contains DI Package
B482Z090
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |