FDA.reportPublic FDA data

Standard Breathing Circuit with Mouthpiece

Primary DI
08697645010079
Brand
Standard Breathing Circuit with Mouthpiece
Company
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
Model
BC21273
Device description
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
Published
2023-06-30
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
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
68697645010071PackageGS140In Commercial Distribution
08697645010079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6869764501007168697645010071
08697645010079086976450100798697645010079

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. 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
Premarket exempt
true
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
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
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
08697645010048Standard Breathing Circuit with Face Mask - ToddlerMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010116Standard Breathing Circuit with Face Mask - Adult MediumMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
08697645010550Standard Breathing Circuit with TrachMEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETICAI2023-06-30
H66860701051Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
H66860701151Mizzy Comfort CushionKeystone IndustriesCAI2022-11-30
10080196082070Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983599Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983933Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983940Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196983971Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2022-08-04
10080196984176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
10080196984343Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAI2021-11-03
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10190752118928Vital Signs™AIRLIFECAI2020-02-20
10190752118942Vital Signs™AIRLIFECAI2020-02-20
10190752118997Vital Signs™VYAIRE MEDICAL, INC.CAI2020-02-20
10190752119130Vital Signs™AIRLIFECAI2020-02-20