Catalog Number

-

Brand Name

ADVANCED PATIENT MONITOR

Version/Model Number

PM-200M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 05, 2028

Issuing Agency

In HIBCC

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

-

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

K131898

Product Code

MWI

Product Code Name

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Public Device Record Key

d06e7590-b34d-4248-ae80-019578c3016f

Public Version Date

April 20, 2020

Public Version Number

1

DI Record Publish Date

April 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-