Catalog Number

E5020-2-NOV

Brand Name

SpiroFlow

Version/Model Number

E5020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 28, 2020

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

f2cd9182-c8c2-452a-b641-4e23f72ef34f

Public Version Date

September 24, 2020

Public Version Number

5

DI Record Publish Date

October 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-