FDA.reportPublic FDA data

CPAP Cleaner

Primary DI
00848530096564
Brand
CPAP Cleaner
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
CAP1003S-80
Device description
Sunset CPAP Mask Cleaning Wipes - 80 Count
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10848530096561PackageGS112In Commercial Distribution
00848530096564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853009656110848530096561
00848530096564008485300965648485300965640848530096564

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning/disinfection wipeA moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00848530080143Wheelchair/Scooter Carrier for E CylindersCSBECSBE2018-07-31
00848530080150Comfort Shoulder Bag for B/M6 CylindersCSBM6CSBM62018-07-31
00848530080167Backpack for B/M6, C/M9 or Smaller CylindersCSBM6BPCSBM6BP2018-07-31
00848530080174Comfort Shoulder Bag for C/M9 CylindersCSBM9CSBM92018-07-31
00848530081942Flex O2 BagCSBM6FlexCSBM6Flex2018-07-31
00848530087173Backpack for D CylindersCSBDBPCSBDBP2018-07-31
00848530087784Cylinder Roller Bag & Backpack — Single D/E TankCSBD1RollerCSBD1Roller2018-07-31
00848530087968Bag for Compressor NebulizerNEB100-BAGNEB100-BAG2018-05-29
00848530108939Ventilator FilterVF005-22026-04-30
00848530108946Ventilator FilterVF003-22026-04-30
00848530108809Ventilator accessoryVEN0072026-04-27
00848530108847CPAP FilterCF1012-2PLC2026-04-27

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
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
10848530096561CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27