FDA.reportPublic FDA data

Circulaire II Hybrid Aerosol Drug Delivery System

Primary DI
00709078000836
Brand
Circulaire II Hybrid Aerosol Drug Delivery System
Company
WESTMED, INC.
Model
0391R
Device description
Reusable VixOne, Mouthpiece, Filter
Published
2016-12-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K926055000
K951484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K926055000THE MILLER NEBULIZER SYSTEMWarren C. Miller1993-02-03CAF
K951484000WESTMED BACTERIAL/VIRAL FILTERWestmed Intl.1995-04-24CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078000833PackageGS110Not in Commercial Distribution
00709078000836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800083310709078000833
00709078000836007090780008367090780008360709078000836

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

Regulatory Flags#

DUNS number
092673953
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078007781Composite Respiratory Kit07992019-10-18
00709078012693Septal-H Infant SizeCP-5500A2021-10-08
00709078012716Septal-H Pediatric SizeCP-5510A2021-10-08
00709078012990CapetteCP-42012021-06-25
00709078013003CapetteCP-42022021-06-25
00709078013010CapetteCP-42032021-06-25
00709078013027CapetteCP-44012021-06-25
00709078013034CapetteCP-44022021-06-25
00709078013041CapetteCP-44032021-06-25
00709078013058StrapetteCP-42042021-06-25
00709078013065StrapetteCP-42202021-06-25
00709078013072StrapetteCP-44042021-06-25
00709078013089StrapetteCP-44202021-06-25
00709078013096ChinstrapCP-51002021-06-25
00709078013102ChinstrapCP-52002021-06-25
00709078013119Septal-HCP-54002021-06-30
00709078013126Septal-HCP-54102021-06-30
00709078013133Septal-HCP-55002021-06-30
00709078013140Septal-HCP-55102021-06-30
00709078013157SavEarRT-61002021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10889483590591AirLife™AirLife Finland OyCAH2025-04-02
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752141834AirLife™VYAIRE MEDICAL, INC.CAH2021-04-09
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752136434Vital Signs™Vyaire GmbHCAH2021-04-02
10190752139589Vital Signs™AirLife Finland OyCAH2021-04-02
10190752141766AirLife™AIRLIFECAF2021-04-02
10190752141940AirLife™AIRLIFECAF2021-04-02
10190752142022AirLife™AIRLIFECAF2021-04-02
10190752146884AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752148185AirLife™AIRLIFECAF2021-04-02
10190752156371AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752156548AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752156555AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752156579AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752156586AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02