Catalog Number

-

Brand Name

M915, Medikro® Pro

Version/Model Number

M9488

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

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

99eea76d-4f75-4701-8660-9f4838caa96e

Public Version Date

March 08, 2022

Public Version Number

4

DI Record Publish Date

July 13, 2018

Package DI Number

06420099000523

Quantity per Package

1

Contains DI Package

06420099000837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-