Catalog Number

-

Brand Name

InHealth Technologies; Blom-Singer

Version/Model Number

IN 4065

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

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

d8852ed3-af5c-418e-92cb-abca8a049aeb

Public Version Date

September 25, 2020

Public Version Number

4

DI Record Publish Date

January 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-