Catalog Number

-

Brand Name

Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit

Version/Model Number

A9242

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

K904538,K904538

Product Code

BZE

Product Code Name

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

Public Device Record Key

768ffe7d-be05-416e-be4f-71533bf76ac2

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

June 25, 2018

Package DI Number

10709078005463

Quantity per Package

10

Contains DI Package

00709078005466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-