Catalog Number

-

Brand Name

Oral/Luer ENFit Transition Connector for medication port

Version/Model Number

F00148

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

-

Product Code

PIO

Product Code Name

Enteral Specific Transition Connectors

Public Device Record Key

8611a229-8728-4b39-b963-8a9b1c6d30a7

Public Version Date

October 28, 2019

Public Version Number

4

DI Record Publish Date

December 28, 2017

Package DI Number

08056093720365

Quantity per Package

80

Contains DI Package

08056093720358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-