Catalog Number

-

Brand Name

EnJoye Metal Luer lock

Version/Model Number

10-0055s3

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K081932

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Public Device Record Key

c37b2b72-7e4f-420b-8dd5-863ff244cc9d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-