Catalog Number

1029435

Brand Name

PERSONAL BEST

Version/Model Number

00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2018

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

K912866

Product Code

BZH

Product Code Name

METER, PEAK FLOW, SPIROMETRY

Public Device Record Key

cbe1a531-405b-4c5e-9636-8201e13aac6f

Public Version Date

September 28, 2018

Public Version Number

5

DI Record Publish Date

August 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-