Catalog Number

02.26.97

Brand Name

RhinoGuard™

Version/Model Number

Large

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 23, 2020

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

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

59eccb1e-ac9f-4885-960e-6f1c6ecb1401

Public Version Date

March 24, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10860622000317

Quantity per Package

10

Contains DI Package

00860622000310

Package Discontinue Date

March 23, 2020

Package Status

Not in Commercial Distribution

Package Type

Box