Catalog Number

-

Brand Name

Clinical Guard

Version/Model Number

CMS500S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Public Device Record Key

0429bae9-7a36-48df-97b0-f136f7a70212

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

March 30, 2017

Package DI Number

20897429002463

Quantity per Package

4

Contains DI Package

10897429002466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-