Catalog Number

0046000

Brand Name

Bard® PreVent® Anti-Reflux Filter

Version/Model Number

0046000

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

FEG

Product Code Name

TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Public Device Record Key

c4573747-95f7-4cc5-a80d-f7a98a517c2e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 16, 2016

Package DI Number

20801741052280

Quantity per Package

10

Contains DI Package

10801741052283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA