Device
SoClean 3+ Automated Supplemental Sleep Equipment Maintenance System
Manufacturer
Soclean, Inc.
Soclean, Inc.
Model: SC1450
Catalog: SC1450-D2C
DI: 00810030570080
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-28
Current Version: 2026-06-05
Description
SoClean 3+ Automated Supplemental Sleep Equipment Maintenance System
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f9be6547-0f41-4f1e-89d3-3fda16f27d5c
Distribution Status:
In Commercial Distribution
DUNS Number:
063054904
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00810030570080
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61383
Name: Home CPAP/BPAP washer-disinfector (ozone)
Definition:
A portable, electrically-powered device designed for the cleaning/disinfection of home positive airway pressure ventilation units (i.e., home CPAP unit, home BPAP unit) and/or masks (e.g., CPAP/BPAP oral mask) using ozone gas as the disinfecting agent. It is a small desktop unit with controls and an integrated ozone generator. It is intended for use in the home but may also be used in healthcare facilities.
FDA Product Codes
QXQ
Respiratory Accessory Microbial Reduction Device.
Premarket Submissions
Submission Number:
K243815
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling Low - @attributes - Value:
-4
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #1 - Storage Handling High - @attributes - Value:
131
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
15
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
95
Item #2 - Storage Handling Type:
Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #3 - Storage Handling Low - @attributes - Value:
50
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #3 - Storage Handling High - @attributes - Value:
90
Item #3 - Storage Handling Type:
Handling Environment Temperature
Item #4 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling Low - @attributes - Value:
15
Item #4 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling High - @attributes - Value:
65
Item #4 - Storage Handling Type:
Handling Environment Humidity