FDA.reportPublic FDA data

CPAP Filter

Primary DI
00848530108137
Brand
CPAP Filter
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
A11FILTER50PK
Device description
Filter, USA, Airsense 11, Standard, 50/Pack
Published
2026-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRLUnit, Filter, Membrane

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRLUnit, Filter, MembraneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530108137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530108137008485301081378485301081370848530108137

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP unit ambient air filter, single-useA non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8775786738customerservice@sunsethcs.com

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
00848530108984CPAP MaskCM206SNH2026-06-04
00848530108991CPAP MaskCM206MNH2026-06-04
00848530109004CPAP MaskCM206LNH2026-06-04
00848530109042CPAP MaskCM207SNH2026-06-04
00848530109059CPAP MaskCM207MNH2026-06-04
00848530109066CPAP MaskCM207LNH2026-06-04
00848530109080CPAP HeadgearHG2062026-06-04
00848530109103CPAP HeadgearHG2072026-06-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530108939Ventilator FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-30
00848530108946Ventilator FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-30
00848530108847CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-27
00848530104733CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-22
00848530108397CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-22
00848530108403CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-22
00848530108410CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-22
00848530108755Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-07
00848530108779Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-07
00848530108786Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-07
00848530108793Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-04-07
00884450834008MiniStop®Merit Medical Systems, Inc.JRL2026-03-20
10884450834005MiniStop®Merit Medical Systems, Inc.JRL2026-03-20
00848530108618CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-19
00848530108472Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-17
00848530108489CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-17
00848530108205Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-09
00848530108212Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-09
10848530108202Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-09
10848530108219Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-03-09
00848530108427Ventilator FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-02-20
00848530108465Bacteria FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-02-20
00848530108267Filter - VentSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-02-02
00848530108298CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-01-27
00848530108106Filter - VentSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107949CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107956CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107963CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107970CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17
00848530107987CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2025-12-17