Catalog Number

-

Brand Name

INVOS

Version/Model Number

CNN/SNN

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

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

-

Product Code

MUD

Product Code Name

Oximeter, tissue saturation

Public Device Record Key

1bc54328-f754-4557-b2f6-99a713ac827a

Public Version Date

September 08, 2022

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

10884521106222

Quantity per Package

10

Contains DI Package

20884521106229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK