Catalog Number

2112540

Brand Name

APEX™

Version/Model Number

2112540

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

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

f90bed2d-e988-4ee1-81dd-7c809cba89c9

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

04046964669729

Quantity per Package

40

Contains DI Package

04046964669736

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton