AccessGUDID - DEVICE: DeVilbiss (00885304000976)

GUDID

Device Identifier (DI) Information

Brand Name: DeVilbiss
Version or Model: 525KS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 525KS
Company Name: DEVILBISS HEALTHCARE LLC

Primary DI Number: 00885304000976
Issuing Agency: GS1
Commercial Distribution End Date: July 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 962175894 *Terms of Use

Device Description: 5-liter oxygen concentrator (international model)

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 [?]
K071397	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 Atmospheric Pressure: between 61 and 101 KiloPascal
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Storage Environment Temperature: between -25 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 10ae70a1-8742-45f8-a445-7de70812450e
Public Version Date: July 18, 2024
Public Version Number: 4
DI Record Publish Date: November 06, 2015