Catalog Number

-

Brand Name

Santamedical

Version/Model Number

SM-165

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)

Yes

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

386666e5-54b3-480a-b877-d6954db894a0

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

February 08, 2018

Package DI Number

10858759005398

Quantity per Package

200

Contains DI Package

00858759005391

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-