Catalog Number

-

Brand Name

Patient Monitor

Version/Model Number

PM-2000A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code

CBQ

Product Code Name

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

Public Device Record Key

9df8c274-89b1-4394-be66-d48a626df9b8

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-