Catalog Number

-

Brand Name

InHealth Technologies; Blom-Singer; Classic

Version/Model Number

IN 2004-LEIR

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

27931858-4888-46f5-9a14-e422cb600ace

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

January 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-