FDA.reportPublic FDA data

Anesthesia Circuit Kit

Primary DI
10889483612149
Brand
Anesthesia Circuit Kit
Company
WESTMED, INC.
Model
R-9303
Device description
Circuit, Pro-N20 Expandable Patient,Elbow, Bifurcated Wye
Published
2024-05-31
Public version status
New
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)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483612146PackageGS120In Commercial Distribution
10889483612149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948361214620889483612146
1088948361214910889483612149

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
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
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10190752120105Vital Signs™AIRLIFEOFP2022-09-05
10190752120815Vital Signs™AIRLIFEOFP2022-09-05
10190752141957AirLife™AIRLIFEOFP2022-09-05
10190752142008AirLife™AIRLIFEOFP2022-09-05
10190752142015AirLife™AIRLIFEOFP2022-09-05
10190752142114AirLife™AIRLIFEOFP2022-09-05
10190752148932AirLife™AIRLIFEOFP2022-09-05
10190752148949AirLife™AIRLIFEOFP2022-09-05
10190752155022AirLife™AIRLIFEOFP2022-09-05
10190752155039AirLife™AIRLIFEOFP2022-09-05
10190752155893AirLife™VYAIRE MEDICAL, INC.OFP2022-09-05
10190752114340AirLife™AIRLIFEOFP2022-08-22
10190752114357AirLife™AIRLIFEOFP2022-08-22
10190752119987Vital Signs™AIRLIFEOFP2022-08-22
10190752144514AirLife™AIRLIFEOFP2022-08-22
10190752148918AirLife™AIRLIFEOFP2022-08-22
10190752148925AirLife™AIRLIFEOFP2022-08-22
10190752152915Vital Signs™AIRLIFEOFP2022-08-22
10190752154865AirLife™AIRLIFEOFP2022-08-22
10190752154872AirLife™AIRLIFEOFP2022-08-22
10190752154889AirLife™AIRLIFEOFP2022-08-22
10190752154896AirLife™AIRLIFEOFP2022-08-22
10190752154902AirLife™AIRLIFEOFP2022-08-22
10190752154919AirLife™AIRLIFEOFP2022-08-22