Catalog Number

-

Brand Name

Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit

Version/Model Number

A9241

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

89940c60-7ea8-4f53-aeca-ddbb0a4f66f7

Public Version Date

December 24, 2019

Public Version Number

3

DI Record Publish Date

May 16, 2018

Package DI Number

10709078004497

Quantity per Package

18

Contains DI Package

00709078004490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-