Catalog Number

-

Brand Name

PleuraFlow® POD

Version/Model Number

PFPD-7515

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"

-

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

a065e57f-2236-4221-9422-d2c80204b289

Public Version Date

October 21, 2021

Public Version Number

4

DI Record Publish Date

July 01, 2018

Package DI Number

10856449006137

Quantity per Package

5

Contains DI Package

00856449006130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box