Catalog Number

DYND70113

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

DYND70113

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

FGD

Product Code Name

CATHETER, RETENTION, BARIUM ENEMA WITH BAG

Public Device Record Key

9a136e48-bf12-4f0d-8a4a-4562f51698d6

Public Version Date

January 13, 2021

Public Version Number

1

DI Record Publish Date

January 05, 2021

Package DI Number

40080196035749

Quantity per Package

10

Contains DI Package

10080196035748

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX