Catalog Number

NP-MINIKIT

Brand Name

DeRoyal

Version/Model Number

NP-MINIKIT

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"

Yes

For Single-Use

Yes

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

K162159

Product Code

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Public Device Record Key

6789f8cc-9b64-4107-9eab-ff915fde3587

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

May 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-