FDA.reportPublic FDA data

Zoey CPAP Cleaner

Primary DI
00848530090890
Brand
Zoey CPAP Cleaner
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
ZCD100
Catalog number
ZCD100
Device description
CPAP Cleaning Device
Published
2020-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MECDisinfector, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530090897PackageGS14In Commercial Distribution
00848530090890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853009089710848530090897
00848530090890008485300908908485300908900848530090890

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.

Contacts#

Phone, Email table
PhoneEmail
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530109127Oxygen, Bacteria & HEPA FilterOF1001BR2026-06-23
00848530109134Oxygen, Bacteria & HEPA FilterOF1005BR2026-06-23
00848530109172Oxygen, Bacteria & HEPA FilterOF11006BR2026-06-23
00848530109189Oxygen, Bacteria & HEPA FilterOF3002BR2026-06-23
00848530109196Oxygen, Bacteria & HEPA FilterOF5001BR2026-06-23
00848530109202Oxygen, Bacteria & HEPA FilterOF6001BR2026-06-23
00848530109219Oxygen, Bacteria & HEPA FilterOF8002BR2026-06-23
00848530109226Oxygen, Bacteria & HEPA FilterOF9001BR2026-06-23
00848530109233Oxygen, Bacteria & HEPA FilterOF9002BR2026-06-23
00848530109240Oxygen, Bacteria & HEPA FilterOF9004BR2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterBF2200BR2026-06-23
00848530109110Suction KitRES026S-KITC2026-06-10
00848530107451Stratus Power SwitchRP0762025-09-24
00848530107468Stratus Pneumatic ValveRP0772025-09-24
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051520024108SteelcoSTEELCO SPAMEC2026-05-26
10841736125257Sterling WashersSKYTRON LLCMEC2026-04-26
08051520022876SteelcoSTEELCO SPAMEC2026-04-17
08051520022852SteelcoSTEELCO SPAMEC2026-03-27
08051520022869SteelcoSTEELCO SPAMEC2026-02-04
04002516952589SteelcoMiele & Cie. KGMEC2026-01-04
04002516952749SteelcoMiele & Cie. KGMEC2026-01-04
04002516952848SteelcoMiele & Cie. KGMEC2026-01-04
04002516952947SteelcoMiele & Cie. KGMEC2026-01-04
10841736125141CleanStartSKYTRON LLCMEC2025-12-19
10841736125158CleanStartSKYTRON LLCMEC2025-12-19
10841736125165CleanStartSKYTRON LLCMEC2025-12-19
10841736125172CleanStartSKYTRON LLCMEC2025-12-19
10841736125189CleanStartSKYTRON LLCMEC2025-12-19
10841736125196CleanStartSKYTRON LLCMEC2025-12-19
10841736125202CleanStartSKYTRON LLCMEC2025-12-19
10841736125219CleanStartSKYTRON LLCMEC2025-12-19
10724995220614VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
00724995220617VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
10841736124427Sterling SKYTRON LLCMEC2025-12-09
10841736124434Sterling SKYTRON LLCMEC2025-12-09
08051520021176SteelcoSTEELCO SPAMEC2025-10-28
08051520021770SteelcoSTEELCO SPAMEC2025-09-24
08051520021763SteelcoSTEELCO SPAMEC2025-09-16
00848530020118CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-28
00848530096564CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530020101CPAP Cleaning SUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530080525 Germicidal Deodorizing CleanserSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530084813CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530087067CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27