FDA.reportPublic FDA data

Breathing Circuit, Adult Corrugated

Primary DI
M485AL1100V0022
Brand
Breathing Circuit, Adult Corrugated
Company
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
Model
AL-1100.V002
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
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M485AL1100V0022PackageHIBCC40In Commercial Distribution
M485AL1100V0021PrimaryHIBCC0

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
565424848
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
10198956137240CARDINAL HEALTHCardinal Health 200, LLCOFP2025-08-11
10889483597422Vital Signs™AIRLIFEOFP2025-03-27
10889483592748Vital Signs™AIRLIFEOFP2025-03-07
10889483599969Vital Signs™AIRLIFEOFP2025-03-07
10889483580035AirLife™AIRLIFEOFP2025-02-20
10889483581513AirLife™AIRLIFEOFP2025-02-20
10889483581520AirLife™AIRLIFEOFP2025-02-20
10889483584118AirLife™AIRLIFEOFP2025-02-20
10889483584125AirLife™AIRLIFEOFP2025-02-20
10889483598207Vital Signs™AIRLIFEOFP2025-02-19
10889483592687Vital Signs™AIRLIFEOFP2025-02-18
10889483595145Vital Signs™AIRLIFEOFP2025-02-18
10889483595596Vital Signs™AIRLIFEOFP2025-02-18
10889483595855AirLife™AIRLIFEOFP2025-02-18
10889483595886AirLife™AIRLIFEOFP2025-02-18
10889483595909AirLife™AIRLIFEOFP2025-02-18
10889483597484Vital Signs™AIRLIFEOFP2025-02-18
10889483584330AirLife™AIRLIFEOFP2025-02-17
10889483584354AirLife™AIRLIFEOFP2025-02-17
10889483584361AirLife™AIRLIFEOFP2025-02-17
10889483584378AirLife™AIRLIFEOFP2025-02-17
10889483584385AirLife™AIRLIFEOFP2025-02-17
10889483596456Vital Signs™AIRLIFEOFP2025-02-17
10889483597699Vital Signs™AIRLIFEOFP2025-02-17
10889483600177Vital Signs™AIRLIFEOFP2025-02-17
10889483600320Vital Signs™AIRLIFEOFP2025-02-17
10889483592588Vital Signs™AIRLIFEOFP2025-02-13
10889483593356Vital Signs™AIRLIFEOFP2025-02-13
10889483600030Vital Signs™AIRLIFEOFP2025-02-05
10889483562789Disposable Anesthesia Breathing Circuit WESTMED, INC.OFP2024-09-06