Catalog Number

000357

Brand Name

Bard Button Device Decompression Tube

Version/Model Number

000357

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

c1670d88-180f-41a2-a879-3c4685913ed0

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

10801741081016

Quantity per Package

6

Contains DI Package

00801741081019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA