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)

-

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

1f8cdfea-80ad-4b37-9c44-28b1d8ba0ac9

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

September 01, 2017

Package DI Number

16945040104480

Quantity per Package

200

Contains DI Package

06945040104483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton