Catalog Number

-

Brand Name

INVOS

Version/Model Number

SNN

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

Yes

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

K091224,K091224,K091224

Product Code

MUD

Product Code Name

Oximeter, tissue saturation

Public Device Record Key

4eafb066-e877-48bd-80d9-58f7df362eae

Public Version Date

February 04, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884521106086

Quantity per Package

10

Contains DI Package

20884521106083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE