Catalog Number

GE41001

Brand Name

Biotronix Healthcare Enema Bag Set

Version/Model Number

GE41001

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"

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

FCE

Product Code Name

Enema Kit

Public Device Record Key

c5f760db-b451-4903-a7a7-7393b241ef78

Public Version Date

December 24, 2019

Public Version Number

2

DI Record Publish Date

October 04, 2019

Package DI Number

10850005165023

Quantity per Package

48

Contains DI Package

00850005165026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case