Catalog Number

-

Brand Name

CHILD PEAKFLOW METER

Version/Model Number

PF-29200

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

-

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

K172804

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Public Device Record Key

32d2ec3c-1e4b-4fa8-b404-c892cea48522

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-