Catalog Number

BE 1055EZ

Brand Name

InHealth Technologies; Blom-Singer; ClassicFlow

Version/Model Number

HME Cartridge ClassicFlow

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

49e53dcd-94c0-4739-8489-825527828fb1

Public Version Date

May 14, 2020

Public Version Number

4

DI Record Publish Date

December 31, 2017

Package DI Number

00848253003009

Quantity per Package

5

Contains DI Package

00848253002996

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-