Catalog Number

-

Brand Name

ECP PSK

Version/Model Number

P-ECP/TI

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

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

K130439

Product Code

DRN

Product Code Name

Device, Counter-Pulsating, External

Public Device Record Key

82f5f650-3f44-4fcc-9263-f3f54973484a

Public Version Date

December 31, 2020

Public Version Number

5

DI Record Publish Date

December 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-