Catalog Number

-

Brand Name

MICRO CIRRUS SMALL PARTICLE NEB

Version/Model Number

1503130

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K911422,K911422

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

d8e53a2c-0a4f-4c9a-9ab4-3304c29f836d

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 04, 2021

Package DI Number

05030267036707

Quantity per Package

100

Contains DI Package

05030267053322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-