Catalog Number

-

Brand Name

B&F

Version/Model Number

61401

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

-

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

-

FDA Premarket Submission

-

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

220d416c-08d8-41b2-970f-f1e975d30b67

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

40026072011124

Quantity per Package

50

Contains DI Package

00026072011126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case