Catalog Number

-

Brand Name

PREVENA PLUS™

Version/Model Number

Prevena Plus 150 ml Canister

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

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

K153199,K153199

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

24a70f46-3ff7-4fde-afb9-65373f89b1c7

Public Version Date

November 23, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

00849554005327

Quantity per Package

5

Contains DI Package

00849554005310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 PACK