Catalog Number

F2321

Brand Name

OptoMonitor 3

Version/Model Number

OpM3 Display Unit 15"

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

K193620

Product Code

DXO

Product Code Name

Transducer, Pressure, Catheter Tip

Public Device Record Key

94bff591-1f56-4a38-9f9f-3bf5a500896c

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-