SoClean

Primary DI: 00810030570011
Brand: SoClean
Company: Soclean, Inc.
Model: SC1450
Catalog number: PN1457-3M
Device description: SC3+ 3-Month Maintenance Kit
Published: 2026-06-10
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: true
Sterile: false
Single use: false

Contact Domains#

soclean.com

Product Codes#

Code, Name table
Code	Name
QXQ	Respiratory Accessory Microbial Reduction Device.

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
QXQ	Respiratory Accessory Microbial Reduction Device.	General Hospital	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K243815	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K243815	000	SoClean 3+	Soclean, Inc.	2025-10-10	QXQ

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00810030570011	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00810030570011	00810030570011	810030570011	0810030570011

GMDN Terms#

Term, Definition table
Term	Definition
Home CPAP/BPAP washer-disinfector (ozone)	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.

Contacts#

Phone, Email table
Phone	Email
866-501-3705	info@soclean.com

Regulatory Flags#

DUNS number: 063054904
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: true
Combination product: false
Lot or batch: true
Serial number: true
Manufacturing date on label: true
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: true
Sterilization required before use: false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00810030570028	SoClean	SC1450	PN1457-6M	2026-06-10
00810030570080	SoClean	SC1450	SC1450-D2C	2026-05-28

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00810030570028	SoClean	Soclean, Inc.	QXQ	2026-06-10
00810030570080	SoClean	Soclean, Inc.	QXQ	2026-05-28