Catalog Number

-

Brand Name

PFM

Version/Model Number

4300

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K781922,K781922,K781922

Product Code

BZH

Product Code Name

METER, PEAK FLOW, SPIROMETRY

Public Device Record Key

6bd94620-04ab-4d76-afe1-0680c9cf17c5

Public Version Date

June 16, 2021

Public Version Number

4

DI Record Publish Date

December 01, 2016

Package DI Number

35099169437037

Quantity per Package

25

Contains DI Package

05099169437036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-