Catalog Number

-

Brand Name

Pleuraflow® System with FlowGlide

Version/Model Number

PFFG3-24

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

OTK

Product Code Name

Wound Drain Catheter System

Public Device Record Key

b0265a85-2848-46da-baf2-d73a3d49d21e

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

March 09, 2021

Package DI Number

10856449006182

Quantity per Package

10

Contains DI Package

00856449006185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack