Catalog Number

3130045

Brand Name

Airzone

Version/Model Number

3130045

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)

-

Over the Counter (OTC)

-

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

c0809e9e-b959-40a3-9bf1-6f6810e8130f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 07, 2016

Package DI Number

05023323001535

Quantity per Package

10

Contains DI Package

05023323001214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-