Catalog Number

-

Brand Name

InHealth Technologies; Blom-Singer; Advantage

Version/Model Number

AS 1614-NS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EPE

Product Code Name

Brush, Cleaning, Tracheal Tube

Public Device Record Key

3047989c-ef08-4c3e-a7cc-2f0956210853

Public Version Date

February 15, 2021

Public Version Number

4

DI Record Publish Date

January 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-