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
00848530108328Repair PartsRP0932026-06-03
00848530109097CPAP MaskCM060S2026-06-03
00848530109264CPAP MaskCM060M2026-06-03
00848530109271CPAP MaskCM060L2026-06-03
00848530109288CPAP MaskCM060XL2026-06-03
00848530108953Repair PartsRP1082026-06-02
00848530108960Repair PartsRP1092026-06-02
00848530108977Repair PartsRP1102026-06-02
00848530109011Repair PartsRP1112026-06-02
00848530109028Repair PartsRP1122026-06-02
00848530109035Repair PartRP1132026-06-02
00848530109073Repair PartsRP1142026-06-02
00848530108854Breathing CircuitVC1001-R2026-05-12
00848530108861Breathing CircuitVC1001P-R2026-05-12
00848530108878Breathing CircuitVEN004-R2026-05-12
00848530080136Comfort Shoulder Bag for D CylindersCSBDCSBD2018-07-31
00848530089214Carry Bag for Portable Suction MachineSU100DC-BAGSU100DC-BAG2018-05-25
00848530100452Nebulizer AccessoriesNEB300-BAG2024-07-30
00848530086503Personal Device HolderCSBML6M72024-06-28
00848530086992Personal Device HolderCSBML6-Hardshell2024-06-28

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