Catalog Number

-

Brand Name

N/A

Version/Model Number

2320030

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

K092129,K092129

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

d3fd94a1-79ec-4073-8973-2b0b96ecc903

Public Version Date

February 07, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

05030267095841

Quantity per Package

30

Contains DI Package

05030267095834

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-