Catalog Number

BSX231

Brand Name

Clever Choice

Version/Model Number

SDCMS50D

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"

Yes

For Single-Use

-

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

DQA

Product Code Name

Oximeter

Public Device Record Key

23dbc09c-43f9-4fd9-9af9-c4163b012023

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

April 07, 2017

Package DI Number

10898302140176

Quantity per Package

24

Contains DI Package

00898302140179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case