FDA.reportPublic FDA data

Filter - Vent

Primary DI
00848530106140
Brand
Filter - Vent
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
VF014FNS
Device description
Luisa Gross Particle Internal Filter - BULK
Published
2025-06-03
Public version status
Update
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
00848530106140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530106140008485301061408485301061400848530106140

GMDN Terms#

Term, Definition table
TermDefinition
Respirator filter/cartridge, particulatesA device designed be attached to a respirator mask body to filter large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses). Filtration occurs in both directions and is achieved with electrostatically charged fibres. This is a reusable device, typically with a limited lifetime.

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
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
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

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
00848530108137CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-01-26
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