Catalog Number

-

Brand Name

B&F

Version/Model Number

64377

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

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

6351affd-b06d-4aaa-bcb5-c0219d40d195

Public Version Date

May 11, 2020

Public Version Number

3

DI Record Publish Date

August 24, 2016

Package DI Number

40026072011247

Quantity per Package

50

Contains DI Package

00026072011249

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case