Catalog Number

-

Brand Name

Medex

Version/Model Number

536035SC

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

K831087,K831087

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

e80c3fef-b3b5-4dcb-816a-ce36d62b2d05

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

50351688516341

Quantity per Package

25

Contains DI Package

10351688516343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE