Catalog Number

-

Brand Name

AsthmaMD

Version/Model Number

G0001-K001

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

-

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Public Device Record Key

edd50f6a-d602-4881-a459-61e3af1625c4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 16, 2016

Package DI Number

20857818006014

Quantity per Package

60

Contains DI Package

10857818006017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton