Catalog Number

ME-050-03-44

Brand Name

Perma Pure

Version/Model Number

ME Series

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

Yes

Prescription Use (Rx)

-

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

e809101a-78f5-4e6c-9b65-dcb32ba0ccce

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

October 09, 2019

Package DI Number

00840106900428

Quantity per Package

50

Contains DI Package

00840106900381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack