Catalog Number

11-50K

Brand Name

VERIDIAN

Version/Model Number

11-50K

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

DQA

Product Code Name

Oximeter

Public Device Record Key

9285ecd1-b6be-4dcb-b74b-97c9545c0da2

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10845717004432

Quantity per Package

48

Contains DI Package

30845717004436

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master