Catalog Number

-

Brand Name

INVOS

Version/Model Number

SAFB-SM/USA

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

K082327,K082327,K082327

Product Code

MUD

Product Code Name

Oximeter, tissue saturation

Public Device Record Key

bf470576-c865-401c-acb6-ab7164d6baad

Public Version Date

June 08, 2022

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521211152

Quantity per Package

20

Contains DI Package

30884521211159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK