Catalog Number

M10600-80

Brand Name

MILL,10 LPM,CONC CANADIAN

Version/Model Number

Millennium M10 Concentrator, CA

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

K043006

Product Code

CAW

Product Code Name

Generator, oxygen, portable

Public Device Record Key

f38a0dae-bb5a-435e-bcce-0a0f401d0b65

Public Version Date

February 25, 2021

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-