Catalog Number

PF30S

Brand Name

Pall® Pro-Tec Filter for Pulmonary Function Testing

Version/Model Number

PF30S

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"

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

K854062,K854062

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

e13998ce-22ea-4032-8395-7ec2202cfed7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 20, 2016

Package DI Number

35034480309144

Quantity per Package

25

Contains DI Package

05034480309143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case