Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

ENPV4280

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080328,K080328

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

e01514da-c36e-4714-b77f-e236364d2c57

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 20, 2017

Package DI Number

20020451331298

Quantity per Package

50

Contains DI Package

00020451331294

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-