FDA.reportPublic FDA data

HEPA Filter

Primary DI
00709078001567
Brand
HEPA Filter
Company
WESTMED, INC.
Model
6234
Device description
w/o CO2 Port
Published
2016-12-23
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
MODAccessory To Continuous Ventilator (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MODAccessory To Continuous Ventilator (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040712000AIR SAFETY HEPA, MODEL 3500Air Safety, Ltd.2004-06-03MOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00709078001567PrimaryGS10
00709078002113Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00709078001567007090780015677090780015670709078001567
00709078002113007090780021137090780021130709078002113

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
100
Lot or batch
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
00850057117493Cart, Display Enclosure 11 inchCORVENT MEDICAL, INCMOD2026-05-26
00850057117509CorVision with DisplayCORVENT MEDICAL, INCMOD2026-05-26
00850057117516CorVent® CorVisionCORVENT MEDICAL, INCMOD2026-05-19
00813841022304Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2023-06-12
10840330700198ProcureTwin Med, LLCMOD2022-11-02
30840330700192ProcureTwin Med, LLCMOD2022-11-02
00813841021260Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021277Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021307Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021567Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021574Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021581Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021611Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021628Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021635Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00813841021642Bio-Med Devices, Inc.BIO-MED DEVICES, INC.MOD2019-10-04
00709078002243HEPA FilterWESTMED, INC.MOD2016-12-30
10709078002240HEPA FilterWESTMED, INC.MOD2016-12-30
00709078000980FilterWESTMED, INC.MOD2016-12-23
00709078001000FilterWESTMED, INC.MOD2016-12-23
00709078001017FilterWESTMED, INC.MOD2016-12-23
10709078000987FilterWESTMED, INC.MOD2016-12-23
10709078001007FilterWESTMED, INC.MOD2016-12-23
10709078001014FilterWESTMED, INC.MOD2016-12-23
15060120952537Respironics Domed (Gherkin)GVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
15060120952544Tyco-Achieva BulkGVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
15060120952551InogenGVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
25060120952534Respironics Domed (Gherkin)GVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
25060120952541Tyco-Achieva BulkGVS FILTER TECHNOLOGY UK LTDMOD2016-09-23
35060120952555InogenGVS FILTER TECHNOLOGY UK LTDMOD2016-09-23