Catalog Number

-

Brand Name

INVOS

Version/Model Number

PMSENS71-A

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

K182868,K182868,K182868,K182868

Product Code

MUD

Product Code Name

Oximeter, tissue saturation

Public Device Record Key

62c6f3ff-c552-4a62-a03b-964f02a31ae8

Public Version Date

September 14, 2022

Public Version Number

11

DI Record Publish Date

March 10, 2019

Package DI Number

20884521556970

Quantity per Package

2

Contains DI Package

20884521556963

Package Discontinue Date

-

Package Status

Not in Commercial Distribution

Package Type

CARTON