Catalog Number

-

Brand Name

PleuraFlow® System with FlowGlide

Version/Model Number

PF-20 SEDL

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

K153681,K153681,K153681

Product Code

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

ad91ffa3-c625-4e0c-844f-f3523f4c8697

Public Version Date

March 08, 2022

Public Version Number

8

DI Record Publish Date

September 23, 2016

Package DI Number

10856449006045

Quantity per Package

10

Contains DI Package

00856449006048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack