FDA.reportPublic FDA data

CPAP Cleaning

Primary DI
00848530020101
Brand
CPAP Cleaning
Company
Sunset Healthcare Solutions, Inc.
Model
CAP1003S
Device description
CPAP Cleaning Wipes - 64 wipes/pack
Published
2025-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
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
00848530020101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530020101008485300201018485300201010848530020101

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530110000Ventilator AccessoryVCMPV001-A2026-11-03
00848530110130Nasal CPAP MaskCM060-KITSLAB2026-11-03
00848530110147Oxygen KitCM060-KITLLAB2026-11-04
00848530110192CPAP MaskCM061SLAB2026-11-04
00848530110208CPAP MaskCM061MLAB2026-11-04
00848530110215CPAP MaskCM061LLAB2026-11-04
00848530110222CPAP MaskCM061XLLAB2026-11-04
00848530110284Oxygen KitAEAG002PKIT2026-11-03
00848530110291Oxygen KitAEAG002CKIT2026-11-03
00848530110307Breathing CircuitVEN004-CAP2026-11-03
00848530109875Ventilator accessoryVCMPV0012026-10-27
00848530110086Oxygen, Bacteria & HEPA FilterBF1412-32026-10-27
00848530093686Oxygen, Bacteria & HEPA FilterBF40002026-10-19
00848530109790Ventilator FilterVF015-12026-10-19
00848530109929Nebulizer and CompressorACTFISH2026-10-19
00848530109936Nebulizer and CompressorACTBEAR2026-10-19
00848530110031Ventilator FilterVF010-502026-10-19
00084853011017CPAP FilterCF1010F-502026-10-14
00848530109745CPAP FilterCF1015-42026-10-14
00848530109844CPAP FilterCF1015-6PL2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04002516952589SteelcoMiele & Cie. KGMEC2026-01-04
04002516952749SteelcoMiele & Cie. KGMEC2026-01-04
04002516952848SteelcoMiele & Cie. KGMEC2026-01-04
04002516952947SteelcoMiele & Cie. KGMEC2026-01-04
00848530020118CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-28
00848530096564CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530080525Germicidal Deodorizing CleanserSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530084813CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530087067CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
04002516883838MieleMiele & Cie. KGMEC2025-07-01
04002516883845MieleMiele & Cie. KGMEC2025-07-01
04002516884781MieleMiele & Cie. KGMEC2025-07-01
04002516884927MieleMiele & Cie. KGMEC2025-07-01
04002516884934MieleMiele & Cie. KGMEC2025-07-01
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10841736121174Skytron Acidic NeutralizerSKYTRON LLCMEC2021-01-15
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10841736121198Skytron Acidic NeutralizerSKYTRON LLCMEC2021-01-15
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