Catalog Number

-

Brand Name

EmpowerSync® Power Supply

Version/Model Number

017353

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"

-

For Single-Use

-

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

IZQ

Product Code Name

Injector, Contrast Medium, Automatic

Public Device Record Key

53be0fd6-3cdd-4a5f-8f9c-3baabca0d0f7

Public Version Date

May 12, 2020

Public Version Number

1

DI Record Publish Date

May 04, 2020

Package DI Number

37630039300945

Quantity per Package

1

Contains DI Package

17630039300958

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box