Catalog Number

-

Brand Name

Docking Station

Version/Model Number

079.0037

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

K142626,K142626

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

fb36adfe-25d8-4066-8963-cab371b6b185

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

October 03, 2016

Package DI Number

07612367038904

Quantity per Package

20

Contains DI Package

07612367024426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-