Catalog Number

-

Brand Name

AnaPod

Version/Model Number

A4070

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 13, 2022

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

-

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

K870173,K870173

Product Code

BTT

Product Code Name

Humidifier, Respiratory Gas, (Direct Patient Interface)

Public Device Record Key

f1192173-a2e0-43a0-9818-dca967f8a1e9

Public Version Date

September 14, 2022

Public Version Number

4

DI Record Publish Date

April 14, 2017

Package DI Number

10709078001182

Quantity per Package

1

Contains DI Package

00709078001185

Package Discontinue Date

September 13, 2022

Package Status

Not in Commercial Distribution

Package Type

-