AccessGUDID - DEVICE: DeVilbiss (00885304001492)

GUDID

Device Identifier (DI) Information

Brand Name: DeVilbiss
Version or Model: 3655PL-IH
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3655PL-IH
Company Name: DEVILBISS HEALTHCARE LLC

Primary DI Number: 00885304001492
Issuing Agency: GS1
Commercial Distribution End Date: January 24, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 962175894 *Terms of Use

Device Description: Compressor / Nebulizer In Home Medical

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?
31253	Medical device air compressor	A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)
BTI	Compressor, Air, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020932	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 -40 and 158 Degrees Fahrenheit
Handling Environment Humidity: less than 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c919006-2abe-425e-9334-c3dd67136b5a
Public Version Date: January 25, 2024
Public Version Number: 4
DI Record Publish Date: September 09, 2016