FDA.reportPublic FDA data

SoClean

Primary DI
00810030570080
Brand
SoClean
Company
Soclean, Inc.
Model
SC1450
Catalog number
SC1450-D2C
Device description
SoClean 3+ Automated Supplemental Sleep Equipment Maintenance System
Published
2026-05-28
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#

Product Codes#

Code, Name table
CodeName
QXQRespiratory Accessory Microbial Reduction Device.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXQRespiratory Accessory Microbial Reduction Device.General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243815000SoClean 3+Soclean, Inc.2025-10-10QXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810030570080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810030570080008100305700808100305700800810030570080

GMDN Terms#

Term, Definition table
TermDefinition
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
063054904
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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