Catalog Number

-

Brand Name

INVOS

Version/Model Number

PM7100

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

-

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,K211561

Product Code

MUD

Product Code Name

Oximeter, tissue saturation

Public Device Record Key

628c21b3-68a8-4583-b0de-dbd91aaec761

Public Version Date

February 08, 2022

Public Version Number

5

DI Record Publish Date

June 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-