Catalog Number

ENF-EXT-060

Brand Name

Ameritus ENFit

Version/Model Number

ENF-EXT-060

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

K120272,K120272,K120272

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

8dd4d504-90ff-40b1-95e3-0456acbf4286

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 03, 2016

Package DI Number

30817522012807

Quantity per Package

800

Contains DI Package

10817522012803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case