Catalog Number

17593

Brand Name

Vista-MX (Gold Edition)

Version/Model Number

17593

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

K864852

Product Code

BZL

Product Code Name

COMPUTER, OXYGEN-UPTAKE

Public Device Record Key

a104ead9-8edd-48ed-90da-874bf8d409ff

Public Version Date

November 15, 2019

Public Version Number

5

DI Record Publish Date

September 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-