Catalog Number

-

Brand Name

ScvO2 function upgrade kit

Version/Model Number

115-046900-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K190011

Product Code

DXG

Product Code Name

Computer, Diagnostic, Pre-Programmed, Single-Function

Public Device Record Key

6bd1b500-5077-4b0d-b24a-3eea620f7262

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

May 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-