Catalog Number

-

Brand Name

INVOS

Version/Model Number

IS

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,K211561,K091224,K211561,K091224,K211561

Product Code

MUD

Product Code Name

Oximeter, tissue saturation

Public Device Record Key

ded1d622-8263-4d20-81d5-3f705d176349

Public Version Date

May 11, 2022

Public Version Number

4

DI Record Publish Date

August 02, 2021

Package DI Number

20884521810362

Quantity per Package

10

Contains DI Package

10884521810365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK