Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

NP-1140-US

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162159,K162159

Product Code

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Public Device Record Key

ad2564b0-1922-4e10-ab50-3d5f4df914b6

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

June 04, 2018

Package DI Number

50749756934782

Quantity per Package

40

Contains DI Package

00749756934787

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case