Catalog Number

36-SWR1134

Brand Name

MicroMedical

Version/Model Number

2.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 27, 2019

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141936

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

4ade8122-699c-45a9-8b55-a081ca4aa475

Public Version Date

March 16, 2021

Public Version Number

5

DI Record Publish Date

March 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-