FDA.reportPublic FDA data

Oxygen Filter

Primary DI
10848530106864
Brand
Oxygen Filter
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
RP045
Device description
Sieve Bed Filter Grid for Invacare PerfectO2 and Platinum
Published
2025-08-06
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
10848530106864PackageGS1100In Commercial Distribution
00848530106867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084853010686410848530106864
00848530106867008485301068678485301068670848530106867

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
false
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
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
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