Catalog Number

10-1014

Brand Name

MED-RX

Version/Model Number

10-1014

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)

-

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

dd4e11a6-865e-44f7-9aaa-8cd02b10a9f0

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

50628725000119

Quantity per Package

50

Contains DI Package

00628725000114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CORRUGATE CASE