Catalog Number

Disposable Flow Sensor

Brand Name

N/A

Version/Model Number

4503

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

Yes

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

K022124,K022124

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Public Device Record Key

e2c0a544-5483-433a-bc51-e1f50fbf2112

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-