Catalog Number

-

Brand Name

QFLOW

Version/Model Number

QFLOW

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161676,K161676

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

f1456be8-9279-4c36-b979-35da846f5194

Public Version Date

August 27, 2018

Public Version Number

5

DI Record Publish Date

May 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-