FDA.reportPublic FDA data

Disposable Heated Humidified Circuit Kit

Primary DI
00709078005114
Brand
Disposable Heated Humidified Circuit Kit
Company
WESTMED, INC.
Model
9655
Device description
FloEasy™ Co-Flo, Disposable Heated Humidified Circuit Kit
Published
2017-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)
OGLOxygen Administration Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1
OGLOxygen Administration KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922492000SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERSpecialty Packaging Producs, Inc.1992-08-24CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078005111PackageGS110In Commercial Distribution
00709078005114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800511110709078005111
00709078005114007090780051147090780051140709078005114

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00709078005107Pulset™3165-912017-09-22
00709078006470Pulset3303-502022-05-31
00709078009082Pulset3173-142020-08-31
00709078011849A-Line3300-242020-09-30
00709078011863A-Line3100-202020-09-30
00709078011900A-Line3300-262020-09-30
00709078012013Pulset36002020-09-30
00709078012037Pulset3600-202020-09-30
00709078013287Atellica® VTR Syringes115613402022-02-28
00709078013300Atellica® VTR Syringes115613412022-02-28
00709078013324Atellica® VTR Syringes115613422022-02-28
00709078013348Atellica® VTR Syringes115613432022-02-28
00709078013362Atellica® VTR Syringes115613442022-02-28
00709078013386Atellica® VTR Syringes115613452022-02-28
00709078013409Atellica® VTR Syringes115613462022-02-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10680651497571HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497588HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497595HalyardO&M HALYARD, INC.OFP2026-06-06
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
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08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
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10889483590591AirLife™AirLife Finland OyCAH2025-04-02
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
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10190752141957AirLife™AIRLIFEOFP2022-09-05
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10190752119987Vital Signs™AIRLIFEOFP2022-08-22
10190752144514AirLife™AIRLIFEOFP2022-08-22
10190752148918AirLife™AIRLIFEOFP2022-08-22
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