FDA.reportPublic FDA data

HEPA Filter

Primary DI
00709078002243
Brand
HEPA Filter
Company
WESTMED, INC.
Model
F300A
Device description
*HEPA Filter with Port and Elbow (6224)
Published
2016-12-30
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
MODAccessory To Continuous Ventilator (Respirator)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078002240PackageGS150Not in Commercial Distribution
00709078002243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800224010709078002240
00709078002243007090780022437090780022430709078002243

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger/microbial medical gas filterA 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.

Regulatory Flags#

DUNS number
092673953
Device count
1
DM exempt
true
Serial number
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
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
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
00709078001567HEPA FilterWESTMED, 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