Veridian - DELUXE PULSE OX FIT OXIMETER - VERIDIAN HEALTHCARE LLC

Duns Number:830437997

Device Description: DELUXE PULSE OX FIT OXIMETER

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More Product Details

Catalog Number

11-50D

Brand Name

Veridian

Version/Model Number

11-50D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

085e3888-6112-4c74-8afa-db95cf71f2d0

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10845717004289

Quantity per Package

24

Contains DI Package

30845717004283

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master

"VERIDIAN HEALTHCARE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 127