Catalog Number

-

Brand Name

InHealth Technologies; Blom-Singer; TruSeal; Contour

Version/Model Number

BE 6071

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

a8619cfc-c6f6-41f7-af5e-1f3e4792f4ae

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 01, 2018

Package DI Number

00813307012528

Quantity per Package

30

Contains DI Package

00848253002729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-