FDA.reportPublic FDA data

Passy Muir

Primary DI
10859760005056
Brand
Passy Muir
Company
PASSY-MUIR, INC.
Model
PM-HME
Catalog number
PM-HME
Device description
Passy Muir Heat Moisture Exchanger
Published
2025-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
10859760005056PrimaryGS10
00859760005059Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085976000505610859760005056
00859760005059008597600050598597600050590859760005059

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-use"A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an ""artificial nose"", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device."

Contacts#

Phone, Email table
PhoneEmail
9498338255info@passymuir.com

Regulatory Flags#

DUNS number
174508630
Device count
30
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859760005059Passy Muir PM-HMEPM-HME2025-02-03
10859760005070Passy-Muir PM-DB15PM-DB152022-08-04
30859760005135Passy-MuirPMV-AD22PMV-AD222024-01-09
10859760005094Passy-Muir PM-OCLNPM-OCLN2022-08-04
10859760005124Passy-MuirPMV-AD1522PMV-AD15222020-08-03
10859760005131Passy-MuirPMV-AD22PMV-AD222020-08-03
10859760005001Passy-Muir PM-APF15PM-APF152024-11-18
00859760005073Passy-Muir PM-DB15PM-DB152022-08-04
10859760005018Passy-MuirPMV 005 PMV 0052016-09-16
10859760005025Passy-MuirPMV 007PMV 0072016-09-16
10859760005032Passy-MuirPMV 2020 PMV 2020 2016-09-16
10859760005063Passy-MuirPMV 2000 PMV 2000 2016-09-16
10859760005087Passy-MuirPMA 2000PMA 20002016-09-16
10859760005148Passy-MuirPMV 2001PMV 20012016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530106430Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2026-08-15
04719874951467Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
04719874955939Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
08904428744916OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
00848530107284Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2025-08-19
14026704927453GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
14026704929723GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
00848530062316Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096922Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096946Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096953Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530103637Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096908Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530083274Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-06-28
00848530083298Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-06-28
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
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07331791002861TrachPhone (50 pcs)Atos Medical ABBYD2022-11-29
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10190752139794AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139800AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139817AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22