Catalog Number

-

Brand Name

InHealth Technologies; Blom-Singer; EasyFlow

Version/Model Number

BE 1055EF6

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

d13570bb-eb50-461a-b380-6bdc9397e6c4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-