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
00709078008818Adaptors/Conectors208438822021-01-29
05707480103195Hyperinflation (AMBU)900 000 6032015-10-24
00709078003028Composite Kit07932017-04-26
00709078003868Humidifier Adaptor04852017-05-26
00709078003899Composite Kit07942017-05-26
00709078005954OxyGo Bubble Humidifier1425-10142018-09-25
00709078007606Bubble Humidifier04802021-02-24
00709078014093Bubble Humidifier10022832022-03-31
00709078014277Bubble Humidifier010-1048582022-03-31
00709078014284Bubble Humidifier10022482022-03-31
00709078003011Composite Kit07922017-04-26
00709078003158Bubble Humidifier07952017-04-26
00709078003349Mod Kit Pulset™3362-912017-03-30
00709078003356Pulset3363-912017-03-30
00709078003974A-Line3100-302021-01-31
00709078004483Pulset3373-912017-08-31
00709078004612Pulset™ 1cc Syringe31002021-04-28
00709078005107Pulset™3165-912017-09-22
00709078006470Pulset3303-502022-05-31
00709078009082Pulset3173-142020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00817081028683PFT KIT F, VBMax 35e Filter KitA-M SYSTEMS, LLCCAH2026-07-17
00848530109257Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-06-23
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
00848530089115Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089139Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089108Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530093839Cough Assist KitSunset Healthcare Solutions, Inc.CAH2025-05-21
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
00848530099503Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530092283Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530104511Oxygen FilterSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530104689Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530105372Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
00848530105389Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-14
008485301044366IN HEPA Capsule with Removable StickerSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104863Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-13
00848530104672Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-04-21
00848530089122Ventilator KitSunset Healthcare Solutions, Inc.CAH2025-04-15
00848530104429Oxygen FilterSunset Healthcare Solutions, Inc.CAH2025-04-15