Catalog Number

-

Brand Name

Neonatal Dual Heated Wire Breathing System 1.6M (Kit 3)

Version/Model Number

038-33-203U

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160540

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

7fc3cb52-1e97-47e6-9f09-ca5fea7487b6

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

February 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-