FDA.reportPublic FDA data

Bacterial Viral Filter

Primary DI
10850014574656
Brand
Bacterial Viral Filter
Company
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
Model
BV002
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
10850014574670PackageGS150In Commercial Distribution
10850014574656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085001457467010850014574670
1085001457465610850014574656

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
M4853116117HME with Flex Tubes311612025-07-09
10850014574649Bacterial Viral FilterBV0012025-07-09
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

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Primary DI, Brand, Company table
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10190752147171AirLife™AIRLIFECAH2020-02-04
10190752147188AirLife™VYAIRE MEDICAL, INC.CAH2020-02-04