Catalog Number

SP0001

Brand Name

Colon Cleansing Nozzle with Flex Tube

Version/Model Number

SP0001

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"

Yes

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

-

Product Code

KPL

Product Code Name

Colonic Irrigation System

Public Device Record Key

6ff07f20-dde0-41b6-a644-26a327be7da8

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

February 10, 2017

Package DI Number

B149SP00011

Quantity per Package

50

Contains DI Package

B149SP0001

Package Discontinue Date

-

Package Status

-

Package Type

Box