AccessGUDID - DEVICE: MILL,10 LPM,CONC CANADIAN (00606959033184)

GUDID

Device Identifier (DI) Information

Brand Name: MILL,10 LPM,CONC CANADIAN
Version or Model: Millennium M10 Concentrator, CA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M10600-80
Company Name: Respironics, Inc.

Primary DI Number: 00606959033184
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: Millennium M10 Concentrator, Canada

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12873	Stationary oxygen concentrator	A stationary mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is typically wheeled but is designed to be placed in one location, e.g., an institution or a home setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAW	Generator, oxygen, portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043006	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and 160 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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