Catalog Number

-

Brand Name

PleuraFlow® System

Version/Model Number

PF-20

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 21, 2018

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

78fee557-7a49-42a9-82c3-4590edbd1725

Public Version Date

March 08, 2022

Public Version Number

7

DI Record Publish Date

September 23, 2016

Package DI Number

10856449006007

Quantity per Package

10

Contains DI Package

00856449006000

Package Discontinue Date

December 21, 2018

Package Status

Not in Commercial Distribution

Package Type

Inner pack