Catalog Number

100520

Brand Name

FloSure

Version/Model Number

FloSure Ventilation Patch

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

K150459,K150459

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

1e9c1dca-c7f5-4f56-8214-55fd25a108f7

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

14260160094292

Quantity per Package

20

Contains DI Package

04260160094295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

white paperboard box