Catalog Number

Contec

Brand Name

Virginia National Guard

Version/Model Number

50DL-B

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

85c86ec5-9fd3-4f21-8fa8-e09dd32466b2

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

January 15, 2018

Package DI Number

20851950008165

Quantity per Package

4

Contains DI Package

10851950008168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-