Catalog Number

-

Brand Name

ENConnect ENFit Stepped Bottle Adapter

Version/Model Number

A540

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

KYX

Product Code Name

Dispenser, Liquid Medication

Public Device Record Key

1bedcae4-210b-4598-ac4d-e2e14cca41ad

Public Version Date

March 07, 2019

Public Version Number

1

DI Record Publish Date

February 04, 2019

Package DI Number

08056093720648

Quantity per Package

24

Contains DI Package

08056093720631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-