Catalog Number

-

Brand Name

InHealth Technologies; Blom-Singer; HumidiFilter

Version/Model Number

BE 1030

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYD

Product Code Name

Condenser, Heat And Moisture (Artificial Nose)

Public Device Record Key

028e7f9a-c198-4ffe-9a27-f392f0b57c7f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 01, 2017

Package DI Number

00813307011804

Quantity per Package

3

Contains DI Package

00848253002415

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-