Catalog Number

450002

Brand Name

CT Enema Administration Kit: Enema Delivery System

Version/Model Number

450002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code

FGD

Product Code Name

Catheter, Retention, Barium Enema With Bag

Public Device Record Key

b210336a-c37b-4449-a81d-3c5c9014826a

Public Version Date

July 22, 2019

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

30815112020201

Quantity per Package

12

Contains DI Package

10815112020207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box