Catalog Number

911105

Brand Name

MIR

Version/Model Number

MIR SPIROBANK SMART

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K072979

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

1897f0a4-49cd-4295-9444-d7dc629bd4d0

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

October 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-