Catalog Number

EN0046100

Brand Name

Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter with ENFit™

Version/Model Number

EN0046100

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

b9794aba-9079-44ae-9682-3fa6bc07e390

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Package DI Number

10801741113229

Quantity per Package

50

Contains DI Package

00801741113222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA