Catalog Number

017353

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

1dfa99bc-b8da-400d-aadc-3484b872e1ca

Public Version Date

November 05, 2019

Public Version Number

1

DI Record Publish Date

October 28, 2019

Package DI Number

37630039301478

Quantity per Package

1

Contains DI Package

17630039301474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box