Catalog Number

000358

Brand Name

Bard Button Device Decompression Tube

Version/Model Number

000358

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

KGC

Product Code Name

TUBE, GASTRO-ENTEROSTOMY

Public Device Record Key

13c6517a-66b6-459a-adf8-51956a85deea

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

20801741081020

Quantity per Package

17

Contains DI Package

10801741081023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX