Catalog Number

017383

Brand Name

EmpowerCTA®+ Injector System with EDA

Version/Model Number

017383

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

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

d97ebe67-cf7e-4e0a-bb9f-e7e440aabaeb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-