Catalog Number

180001

Brand Name

Kit, Reusable Turbine With Mouthpiece, For MIR SmartOne

Version/Model Number

Kit, Reusable Turbine With Mouthpiece - 180001

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

BYP

Product Code Name

Mouthpiece, Breathing

Public Device Record Key

cb54500c-9ee5-49d7-b83a-9c9d903527b7

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

March 09, 2020

Package DI Number

00817081025453

Quantity per Package

1

Contains DI Package

00817081025446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-