Catalog Number

-

Brand Name

MIR

Version/Model Number

MIR Spirobank II New BLE spirometer

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061712

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

6972ad1d-a8d0-4291-830b-e369d2daf444

Public Version Date

March 19, 2021

Public Version Number

5

DI Record Publish Date

October 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-