Catalog Number

HS002068-010

Brand Name

ASTHMACHECK

Version/Model Number

HS002068-010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K962924

Product Code

BZH

Product Code Name

METER, PEAK FLOW, SPIROMETRY

Public Device Record Key

ed54f2b8-6a3a-456f-8c6d-3755bba6cab9

Public Version Date

February 19, 2020

Public Version Number

1

DI Record Publish Date

February 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-