FDA.reportPublic FDA data

ABC - Duoflow Bi-lumen Breathing Circuit

Primary DI
00841470106737
Brand
ABC - Duoflow Bi-lumen Breathing Circuit
Company
ENGINEERED MEDICAL SYSTEMS INC
Model
D072323M0X1A4
Published
2025-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10841470106734PackageGS110In Commercial Distribution
00841470106737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010673410841470106734
00841470106737008414701067378414701067370841470106737

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Regulatory Flags#

DUNS number
154502934
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841470106218ABC -Flex Tube SystemF060323M3X1E42025-04-11
00841470106263ABC - Uniflow Breathing CircuitU060323M1X1E42025-04-11
00841470106287ABC - Duoflow Bi-lumen Breathing CircuitD072323M2X1E42025-04-11
00841470106348ABC - Flex Tube SystemF060323M0X1E52025-04-11
00841470106577ABC - Compact Breathing CircuitC120323M0X1A42025-04-11
00841470106584ABC - Compact Breathing CircuitC120323M0X1E52025-04-11
00841470107116ABC - Uniflow Breathing CircuitU072323M0X1A42025-04-11
00841470107659ABC - Uniflow Breathing CircuitU096323M0X1A42025-04-11
00841470108625ABC - Flex Tube SystemF96M317M0X1A42025-04-11
00841470108731ABC - Duoflow Bi-lumen Breathing CircuitD12M317M1X1A42025-04-11
00841470108847ABC - Pediatric Compact Breathing CircuitPC12123M900002025-04-11
00841470108946ABC - Duoflow Bi-lumen Breathing CircuitD72M317M1X1A42025-04-11
00841470108953ABC - Pediatric Compact Breathing CircuitPC12113M0X5002025-04-11
00841470109455ABC - Compact Breathing CircuitC120323M0X1C52025-04-11
00841470109486ABC - Compact Breathing CircuitC072323M1X1A42025-04-11
00841470109493ABC - Compact Breathing CircuitC120323M1X1E52025-04-11
00841470109509ABC - Duoflow Bi-lumen Breathing CircuitD120323M1X1A42025-04-11
00841470109523ABC - Uniflow Breathing CircuitU072323M0X1002025-04-11
00841470109530ABC - Uniflow Breathing CircuitU072323M0X1E52025-04-11
00841470111700Disposable Pressure Manometer313-40002025-04-12

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