Catalog Number

10-1300

Brand Name

MED-RX

Version/Model Number

10-1300

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

f1f7c67a-0854-46bd-81ef-5e26b37ebc74

Public Version Date

January 03, 2019

Public Version Number

2

DI Record Publish Date

November 26, 2018

Package DI Number

50628725000898

Quantity per Package

50

Contains DI Package

00628725000893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

corrugate case