Catalog Number

186005833IVD

Brand Name

Xevo

Version/Model Number

186005833IVD

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

DOP

Product Code Name

Mass Spectrometer, Clinical Use

Public Device Record Key

2f0e03e3-b6a2-4f30-b2b0-bb90773b5a16

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

October 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-