FDA.reportPublic FDA data

Filter

Primary DI
10709078001113
Brand
Filter
Company
WESTMED, INC.
Model
A4334
Device description
72" 28V Pediatric HW Circuit, Par-Wye, GSE, BV Filter, Water, 1L/Lf Bag
Published
2017-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078001113PackageGS118In Commercial Distribution
00709078001116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800111310709078001113
00709078001116007090780011167090780011160709078001116

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger/microbial filter, non-sterileA non-sterile device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10197344176434HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176441HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176458HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176465HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344011629HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-01-21
10889483572122AirLife™AIRLIFEBZE2025-03-27
10889483572658AirLife™AIRLIFEBZE2025-03-05
10889483572283AirLife™AIRLIFEBZE2025-02-17
10889483572672AirLife™AIRLIFEBZE2025-02-17
10889483572528AirLife™AIRLIFEBZE2025-02-12
10889483572559AirLife™AIRLIFEBZE2025-02-12
10889483572610AirLife™AIRLIFEBZE2025-02-12
10889483572689AirLife™AIRLIFEBZE2025-02-12
10889483572818AirLife™AIRLIFEBZE2025-02-12
10889483572825AirLife™AIRLIFEBZE2025-02-12
10889483572870AirLife™AIRLIFEBZE2025-02-12
09420012448422Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012453204Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012459213Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
10197344043040HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043057HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043088HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043095HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
09420012431080Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012431165Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012432162Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012456601Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
10190752147713AirLife™AIRLIFEBZE2021-05-07
10190752152939AirLife™AIRLIFEBZE2021-05-07
10190752152946AirLife™AIRLIFEBZE2021-05-07