Catalog Number

-

Brand Name

Firefly Luer Cover

Version/Model Number

40401

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2016

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

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

KDJ

Product Code Name

Set, Administration, For Peritoneal Dialysis, Disposable

Public Device Record Key

49a3758b-6af1-44e8-b98e-ffe7b7d9e185

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

November 21, 2016

Package DI Number

865349000346

Quantity per Package

8

Contains DI Package

00865349000339

Package Discontinue Date

December 01, 2016

Package Status

Not in Commercial Distribution

Package Type

box