Catalog Number

-

Brand Name

Repatha Pushtronex System

Version/Model Number

9002870

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

eb34cc76-f0e7-4ab9-b0ec-73c8aa905977

Public Version Date

October 02, 2019

Public Version Number

1

DI Record Publish Date

September 24, 2019

Package DI Number

10355513770016

Quantity per Package

20

Contains DI Package

00355513770019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case