Catalog Number

-

Brand Name

Avance Flex 2.0 Negative Pressure Wound Therapy Pump

Version/Model Number

APR100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 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

-

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

fbf61e68-dc55-4a1c-8308-6b3eda70f771

Public Version Date

July 19, 2021

Public Version Number

2

DI Record Publish Date

May 01, 2018

Package DI Number

00860385000800

Quantity per Package

1

Contains DI Package

00860385000855

Package Discontinue Date

August 31, 2020

Package Status

Not in Commercial Distribution

Package Type

Box