FDA.reportPublic FDA data

Filter - Vent

Primary DI
10848530108103
Brand
Filter - Vent
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
VF005-10
Device description
Sunset Particle Filter for Respironics Trilogy Ventilator – 10/PK
Published
2025-12-17
Public version status
New
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
JRLUnit, Filter, Membrane

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848530108103PackageGS110In Commercial Distribution
20848530108100PackageGS180In Commercial Distribution
00848530108106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853010810310848530108103
2084853010810020848530108100
00848530108106008485301081068485301081060848530108106

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction filterA sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). 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
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
false
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
00848530109141Oxygen, Bacteria & HEPA FilterOF11003BR2026-06-30
00848530109165Oxygen, Bacteria & HEPA FilterOF11005BR2026-06-30
00848530109295Oxygen kitAATH006O2KIT2026-06-11
00848530109462Nasal CPAP MaskCM060-KITLNV2026-07-15
00848530109479Nasal CPAP MaskCM060L-NV2026-07-15
00848530109486Nasal CPAP MaskCM060XL-NV2026-07-15
00848530109523Oxygen KitAHOW001O2KIT2026-08-20
00848530109592Ventilator FilterVF010-12026-08-20
00848530109608Ventilator FilterVF010F-12026-08-20
00848530109639Nasal CPAP MaskCM060SNH2026-08-24
00848530109646Nasal CPAP MaskCM060MNH2026-08-24
00848530109653CPAP MaskCM061SNH2026-08-24
00848530109660CPAP MaskCM061MNH2026-08-24
00848530109691CPAP HeadgearHG060B2026-09-09
00848530109721OXYGEN CONNECTOR/ADAPTERRES019-1PL2026-09-09
00848530109738CPAP FilterCF1015NS2026-08-31
00848530109783Oxygen AccessoryPOCBAG-P22026-09-09
00848530109813AerosolTUB100-1FT15MM2026-09-09
00848530109820Ventilation AccessoryVEN008NS2026-09-09
00848530109837Ventilation AccessoryRES096MPNS2026-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00084853000905Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.JRL2025-06-18
00848530031046CPAP FilterSunset Healthcare Solutions, Inc.JRL2025-05-16
00848530032753CPAP FilterSunset Healthcare Solutions, Inc.JRL2025-05-16
00789091681618CPAP FilterSunset Healthcare Solutions, Inc.JRL2025-05-13
00789091681625CPAP FilterSunset Healthcare Solutions, Inc.JRL2025-05-13
00848530001261CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030346CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030728CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030902CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030957CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530031435CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032043CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032050CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032098CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032159CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032685CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032692CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032708CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032715CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032722CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032739CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032746CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032760CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032777CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032791CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032807CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032814CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032821CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530032838CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-26
00848530030094CPAP FilterSunset Healthcare Solutions, Inc.JRL2024-07-25