FDA.reportPublic FDA data

Stratus 5 Kit

Primary DI
00848530104122
Brand
Stratus 5 Kit
Company
SUNSET HEALTHCARE SOLUTIONS, INC.
Model
OF6030SP
Device description
1- OF6030 1- BF6020 1-BF516
Published
2024-06-06
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
CAHFilter, Bacterial, Breathing-Circuit
JRLUnit, Filter, Membrane

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2
JRLUnit, Filter, MembraneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848530104122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848530104122008485301041228485301041220848530104122

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
877-578-6738customerservice@sunsethcs.com

Regulatory Flags#

DUNS number
141668116
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848530060725Bubble Humidifiers - 6psiRES050RES0502018-07-31
00848530060732Bubble Humidifiers - 6psiRES050-50RES050-502018-07-31
00848530062064Bubble Humidifiers - 6psiRES050-1RES050-12018-07-31
00848530108557CPAP FilterCF1013-22026-08-26
00848530090890Zoey CPAP CleanerZCD100ZCD1002020-02-28
00848530106430Heat Moisture ExchangerRES027SG2026-08-15
00848530109677CPAP Mask KitCM061-KITS2026-08-15
00848530109684CPAP Mask KitCM061-KITL2026-08-15
00848530109455Oxygen AccessoryRES031M-12026-07-23
00848530109509Ventilator FilterVIVOFILTERKIT2026-07-23
00848530109516CPAP FilterCF40042026-07-23
00848530109127Oxygen, Bacteria & HEPA FilterOF1001BR2026-06-23
00848530109134Oxygen, Bacteria & HEPA FilterOF1005BR2026-06-23
00848530109172Oxygen, Bacteria & HEPA FilterOF11006BR2026-06-23
00848530109189Oxygen, Bacteria & HEPA FilterOF3002BR2026-06-23
00848530109196Oxygen, Bacteria & HEPA FilterOF5001BR2026-06-23
00848530109202Oxygen, Bacteria & HEPA FilterOF6001BR2026-06-23
00848530109219Oxygen, Bacteria & HEPA FilterOF8002BR2026-06-23
00848530109226Oxygen, Bacteria & HEPA FilterOF9001BR2026-06-23
00848530109233Oxygen, Bacteria & HEPA FilterOF9002BR2026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530108557CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-08-26
B462100053363PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
B462100053393PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
10612479284002McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284026McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284040McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284064McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284101McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284125McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
14026704927736GIBECKTELEFLEX INCORPORATEDCAH2026-08-01
14026704928993GIBECKTELEFLEX INCORPORATEDCAH2026-07-28
00848530109509Ventilator FilterSUNSET HEALTHCARE SOLUTIONS, INC.CAH2026-07-23
00848530109516CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-07-23
00817081028683PFT KIT F, VBMax 35e Filter KitA-M SYSTEMS, LLCCAH2026-07-17
00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipA-M SYSTEMS, LLCCAH2026-06-23
00848530109127Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109134Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109172Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109189Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109196Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109202Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109219Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109226Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109233Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109240Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.JRL2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.CAH2026-06-23
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17