FDA.reportPublic FDA data

Oxygen Filters

Primary DI
10848530099685
Brand
Oxygen Filters
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
OF2000
Device description
Sieve Bed Filter 4.125" for EverFlo - 5/pack
Published
2024-07-30
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
false

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
00848530099688PrimaryGS10
10848530099685Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530099688008485300996888485300996880848530099688
1084853009968510848530099685

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
25
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
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