Catalog Number

-

Brand Name

ENFit to Reverse Luer Transition Connector

Version/Model Number

F00126

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

K162254,K162254,K162254

Product Code

PIO

Product Code Name

Enteral Specific Transition Connectors

Public Device Record Key

c798d2f1-4d0e-4a4a-80fa-4b475ae33d29

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 28, 2017

Package DI Number

08056093720037

Quantity per Package

80

Contains DI Package

08056093720020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-