Catalog Number

ENF60-KSBC

Brand Name

Ameritus ENFit

Version/Model Number

ENF60-KSBC

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

K162188,K162188,K162188,K162188

Product Code

PNR

Product Code Name

Enteral Syringes With Enteral Specific Connectors

Public Device Record Key

7d9e14b2-7728-48ce-953e-8e6f7f7592db

Public Version Date

October 29, 2021

Public Version Number

5

DI Record Publish Date

March 28, 2019

Package DI Number

30817522011541

Quantity per Package

400

Contains DI Package

10817522011547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case