Catalog Number

-

Brand Name

CONTEC

Version/Model Number

CMS50DL

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)

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

c0908f6a-78c1-458f-8ef2-c8c498fc8664

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

16945040100796

Quantity per Package

100

Contains DI Package

06945040100799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton