HEAT AND MOISTURE EXCHANGER FOR TRACHEOSTOMY HYDROPHOBIC PAPER

Primary DI
04816415501119
Brand
HEAT AND MOISTURE EXCHANGER FOR TRACHEOSTOMY HYDROPHOBIC PAPER
Company
ASSOMEDIKA, OOO
Model
Fl52005
Device description
"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."
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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
04816415501119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04816415501119048164155011194816415501119

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."

Regulatory Flags#

DUNS number
683522555
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04816415501379LARYNGEAL MASK Single Use Size 2N/A2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3N/A2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5N/A2026-05-27
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmN/A2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmN/A2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmN/A2026-05-27
04816415501430BREATHING BAG single use 500N/A2026-05-27
04816415501447BREATHING BAG single use 1000N/A2026-05-27
04816415501454BREATHING BAG single use 2000N/A2026-05-27
04816415501461BREATHING BAG single use 3000N/A2026-05-27
04816415501478BREATHING BAG reusable 500N/A2026-05-27
04816415501485BREATHING BAG reusable 1000N/A2026-05-27
04816415501492BREATHING BAG reusable 2000N/A2026-05-27
04816415501508BREATHING BAG reusable 3000N/A2026-05-27
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEN/A2026-05-26
04816415501263FOOT URINE COLLECTORN/A2026-05-26
04816415501270BEDSIDE URINE COLLECTORN/A2026-05-26
04816415501287BREATHING MASK Single Use Size 0N/A2026-05-26
04816415501294BREATHING MASK Single Use Size 3N/A2026-05-26
04816415501300BREATHING MASK Single Use Size 6N/A2026-05-26

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