Catalog Number

50002-0860-38

Brand Name

Clever Choice Peak Flow Meter

Version/Model Number

SDI-PFM

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172804,K172804

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Public Device Record Key

e000aa60-9da1-457e-884b-18811a2ae305

Public Version Date

November 12, 2019

Public Version Number

1

DI Record Publish Date

November 04, 2019

Package DI Number

10850002860389

Quantity per Package

40

Contains DI Package

00850002860382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case