Catalog Number

EN0036430

Brand Name

Bard® Premature Infant Feeding Tube with ENFit™

Version/Model Number

EN0036430

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2022

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

FPD

Product Code Name

TUBE, FEEDING

Public Device Record Key

a6cf49e0-9223-469b-b5c3-28c2fa58683d

Public Version Date

May 18, 2022

Public Version Number

3

DI Record Publish Date

October 19, 2016

Package DI Number

20801741113202

Quantity per Package

200

Contains DI Package

10801741113205

Package Discontinue Date

October 31, 2019

Package Status

Not in Commercial Distribution

Package Type

CA