FDA.reportPublic FDA data

HME Filter

Primary DI
00819989014911
Brand
HME Filter
Company
EXCELERON MEDICAL, INC.
Model
HME-T
Device description
Heat Moisture Exchanger, T configuration
Published
2021-07-26
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
BYDCondenser, Heat And Moisture (Artificial Nose)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819989014911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819989014911008199890149118199890149110819989014911

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
825179992
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819989011576Thermalite Heated CPAP TubeCTUB-06H15DS2025-01-10
00812970012002NuwaveNW-001NW-0012020-09-23
00812970012019NuwaveNW-002NW-0022020-09-23
00812970012026NuwaveNW-003NW-0032020-09-23
00812970012033NuwaveNW-004NW-0042020-09-23
00812970012040NuwaveUSB-PWR-ADPT-ULUSB-PWR-ADPT-UL2020-09-23
00812970012057NuwaveUSB-PWR-CORDUSB-PWR-CORD2020-09-23
00812970012064NuwaveUSB-PWR-ADPT-KITUSB-PWR-ADPT-KIT2020-09-23
00812970012071NuwaveNUWAVE-BG-SMNUWAVE-BG-SM2020-09-23
00812970012088NuwaveNUWAVE-BG-LGNUWAVE-BG-LG2020-09-23
00812970012095NuwaveCO-001CO-0012020-09-23
00812970012101NuwaveCO-001-KTCO-001-KT2020-09-23
00819989011187CPAP TubingCTUB-018-12021-05-24
00819989011002CPAP TubingCTUB-010-12020-09-24
00819989011026CPAP TubingCTUB-06S-12020-09-23
00819989011040CPAP TubingCTUB-060-12020-09-23
00819989011064CPAP TubingCTUB-080-12020-09-23
00819989011088CPAP TubingCTUB-090-12020-09-23
00819989011101CPAP TubingCTUB-100-12020-09-23
00819989011125CPAP TubingCPAP-TUBE-6FT-SPL-12020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08904428745067OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
10884389976067MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
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10889483334577AirLife™AIRLIFEBYD2025-02-20
10889483571545AirLife™AIRLIFEBYD2025-02-20
10889483571569AirLife™AIRLIFEBYD2025-02-20
10889483571613AirLife™AIRLIFEBYD2025-02-20
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10859760005056Passy Muir PASSY-MUIR, INC.BYD2025-02-03
10810050855621ThermoFlo®TYPENEX MEDICAL LLCBYD2024-11-14
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
10850014574793HME FlexPEPPER MEDICAL INC.BYD2023-10-25
10884521082502DARCovidien LPBYD2023-09-16
10884521829060DARCovidien LPBYD2023-09-16
10884521829152DARCovidien LPBYD2023-09-16
10884521829183DARCovidien LPBYD2023-09-16
10884521829190DARCovidien LPBYD2023-09-16
10884521829206DARCovidien LPBYD2023-09-16
10884521829213DARCovidien LPBYD2023-09-16
10884521829220DARCovidien LPBYD2023-09-16
10884521829176DARCovidien LPBYD2023-09-01
10888277702202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BYD2023-01-26
10840330700181ProcureTwin Med, LLCBYD2022-11-02
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05