Catalog Number

01VB0100

Brand Name

N/A

Version/Model Number

Nebuliser Handset

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 20, 2019

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

K090730

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

adeef997-224e-4866-ac33-dc12d6bf22d7

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

June 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-