Catalog Number

-

Brand Name

PleuraFlow® System with FlowGlide

Version/Model Number

PFFG-24 XDL

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

6b63f687-1701-4649-95c7-964dfe937b8a

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2018

Package DI Number

20856449006103

Quantity per Package

1

Contains DI Package

10856449006106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case