Catalog Number

-

Brand Name

Drive

Version/Model Number

MQ8500

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

-

Product Code

BZH

Product Code Name

METER, PEAK FLOW, SPIROMETRY

Public Device Record Key

d16dd716-0318-4488-8f2d-0f5c05ddccc4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

10822383539420

Quantity per Package

10

Contains DI Package

00822383539423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-