Catalog Number

-

Brand Name

MIR

Version/Model Number

Smart One USA

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"

Yes

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

K181666

Product Code

BZH

Product Code Name

Meter, Peak Flow, Spirometry

Public Device Record Key

74f0f86e-07c2-45c6-96d4-e11927fcf0b7

Public Version Date

December 03, 2021

Public Version Number

3

DI Record Publish Date

November 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-