Virtuox - Nonin compatible neonatal disposable probes, case - HEALTHCARE LOGISTICS SYSTEMS LLC

Duns Number:079452927

Device Description: Nonin compatible neonatal disposable probes, case of 24

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More Product Details

Catalog Number

-

Brand Name

Virtuox

Version/Model Number

1803

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100077,K100077

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

7bf42fc4-6161-4391-bb43-ac028a85cf1a

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

December 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEALTHCARE LOGISTICS SYSTEMS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22