Catalog Number

-

Brand Name

Vitalcontrol

Version/Model Number

SPO25

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PGJ

Product Code Name

Oximeter, Wellness

Public Device Record Key

817e55ca-5df8-4c96-8982-3c5d0490cfe5

Public Version Date

August 11, 2022

Public Version Number

3

DI Record Publish Date

August 30, 2021

Package DI Number

10850018808085

Quantity per Package

4

Contains DI Package

00850018808088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner case