Catalog Number

-

Brand Name

Filter

Version/Model Number

A38605HP

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"

Yes

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

BZE

Product Code Name

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Public Device Record Key

db73724f-2d57-4436-a3d1-235b7801d018

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

April 14, 2017

Package DI Number

10709078001137

Quantity per Package

18

Contains DI Package

00709078001130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-