Catalog Number

-

Brand Name

Heated Circuit

Version/Model Number

9313

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

3bba506c-dbb6-42f6-aaa6-c74a063f9d0e

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

November 24, 2016

Package DI Number

10709078001083

Quantity per Package

18

Contains DI Package

00709078001086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-