FDA.reportPublic FDA data

HME with Flex Tubes

Primary DI
M4853116117
Brand
HME with Flex Tubes
Company
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
Model
31161
Device description
A 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.
Published
2025-07-09
Public version status
New
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
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192713000Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS2020-03-16CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M4853116128PackageHIBCC50In Commercial Distribution
M4853116117PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
565424848
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850014574649Bacterial Viral FilterBV0012025-07-09
10850014574656Bacterial Viral FilterBV0022025-07-09
10850014574694Heat Moisture Exchanger with FilterHME7122025-07-09
10850014574663Bacterial Viral FilterBV0012025-07-09
10850014574670Bacterial Viral FilterBV0022025-07-09
10850014574687Heat Moisture Exchanger with FilterHME7122025-07-09
M4853116128HME with Flex Tubes311612025-07-09
M485AL08021V0011Bacterial-Viral HME FilterAL-08021.V0012023-08-10
M485AL1100V0021Breathing Circuit, Adult CorrugatedAL-1100.V0022023-08-10
M485AL1400V0051Breathing Circuit, Pediatric, CorrugatedAL-1400.V0052023-08-10
M485AL08021V0012Bacterial-Viral HME FilterAL-08021.V0012023-08-10
M485AL1100V0022Breathing Circuit, Adult CorrugatedAL-1100.V0022023-08-10
M485AL1400V0052Breathing Circuit, Pediatric, CorrugatedAL-1400.V0052023-08-10
08697645010048Standard Breathing Circuit with Face Mask - ToddlerBC210872023-06-30
08697645010079Standard Breathing Circuit with MouthpieceBC212732023-06-30
08697645010116Standard Breathing Circuit with Face Mask - Adult MediumBC210892023-06-30
08697645010550Standard Breathing Circuit with TrachBC210902023-06-30
68697645010040Standard Breathing Circuit with Face Mask - ToddlerBC210872023-06-30
08697645010055Standard Breathing Circuit with Face Mask - Child/Adult SmallBC210882023-06-30
08697645010062Standard Breathing Circuit with MouthpieceBC210922023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10193489339826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAH2022-08-04
10193489139990MedlineMEDLINE INDUSTRIES, INC.CAH2022-08-03
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
10193489019452HYDRO-GUARD MINI BREATHING FILTER Intersurgical IncorporatedCAH2021-10-05
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10190752136809Vital Signs™AirLife Finland OyCAH2021-03-05
10190752138094Vital Signs™VYAIRE MEDICAL, INC.CAH2021-03-05
10190752139107Vital Signs™AirLife Finland OyCAH2021-03-05
10190752139558Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140080Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140097AirLife™AirLife Finland OyCAH2021-03-05
10190752136724Vital SignsAirLife Finland OyCAH2021-03-01
10190752147171AirLife™AIRLIFECAH2020-02-04
10190752147188AirLife™VYAIRE MEDICAL, INC.CAH2020-02-04