Catalog Number

-

Brand Name

ADVANCED PATIENT MONITOR

Version/Model Number

PM-2000XL PLUS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 15, 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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120631

Product Code

CBQ

Product Code Name

Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

Public Device Record Key

39d6d1d2-73ef-42ff-bb8c-7d89d2d2303f

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

April 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-