FDA.reportPublic FDA data

Ventilator breathing circuit, reusable

Definition
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, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. 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. This is a reusable device.
GUDID devices
365
Last updated
2026-10-04 01:13:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05404013001507ClassicPlastiflex GroupClassic FL 152026-09-21
05404013001521ClassicPlastiflex GroupClassic FL 192026-09-21
05404013004560HybernitePlastiflex Group NVComfortLine Heated Tubing2022-07-03
00810178885602ViveVIVE HEALTH LLCLVA2014PAK22026-08-03
00818323027358ViveVIVE HEALTH LLCLVA20142026-08-03
00026072022238EMAllied Medical, LLCL599-1902024-05-28
00606959043022TrilogyRespironics, Inc.Trilogy, Mouthpiece Ventilation Disposable Circuit2016-09-28
00619498213269N/AIntersurgical IncorporatedRM213262015-09-17
00619498391028CLIMATELINEAIR 11RESMED PTY LTD391022021-03-31
0081647202310822mm Smoothbore breathing systemIntersurgical Incorporated518360002023-06-19
04026704580552HUDSON RCITELEFLEX INCORPORATEDIPN0429322018-09-15
04719894380865VADI MEDICALVADI MEDICAL TECHNOLOGY CO., LTD.G-3300002024-02-16
04719894380889VADIVADI MEDICAL TECHNOLOGY CO., LTD.G-329011-12023-10-16
04719894380896VADIVADI MEDICAL TECHNOLOGY CO., LTD.G-328001-12023-10-16
050302670581812MM FLEXTUBE BREATHING SYSTEM. 1.6MIntersurgical Incorporated20000002021-10-14
0503026706956922MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6MIntersurgical Incorporated51130182024-09-16
0503026706973622MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH CONTROL LINE 1.6M Intersurgical Incorporated51820002021-10-06
0503026706975022MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE 1.6MIntersurgical Incorporated51830002021-10-06
0503026706986622MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINEIntersurgical Incorporated51910002021-10-06
05404013000012HybernitePlastiflex Group NVHybernite HBT US2016-09-15
05404013000098HybernitePlastiflex Group NVHybernite ROC US2016-09-15
05404013000104HybernitePlastiflex Group NVComfortline 3B2016-09-15
05404013000159HybernitePlastiflex Group NVHBT IntelliPAP2016-09-15
05404013000173HybernitePlastiflex Group NV3BCL 1010 3B ComfortLine2016-09-15
05404013000180HybernitePlastiflex Group NVHybernite HBT white US2016-09-15
05404013000982HybernitePlastiflex Group NVSleepbox Heated Tube2017-07-13
05404013001484ClassicPlastiflex Group NVClassic 19 US2019-03-05
05404013002221ClassicPlastiflex Group NVClassic 19 Black 18302019-03-03
06923980108693MindrayGaleMed Xiamen Co., Ltd.XMR01272024-07-19
07321820060931Vivo SeriesBreas Medical AB0060932022-06-18
07325710002568Hytrel slang 10mm 30cmMaquet Critical Care AB66923172015-10-30
08500501360228BiWaze Clear Dual Lumen Circuit With Face Mask - InfantAbmrc LLCBK9022026-05-20
08500501360235BiWaze Clear Dual Lumen Circuit - AcuteAbmrc LLCBK9092026-05-20
09420012429162Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900ICON2082016-09-10
09420012432247Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900MR8102016-09-08
09420012432254Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900MR810E2022-08-02
09420012432957Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900HC5222016-09-10
09420012442260Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900SPS1212019-05-12
09420012442277Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITED900SPS1202019-05-12
10190752136946Vital Signs™AirLife Finland OyM10363792022-06-16
10197344176434HUDSON RCIMEDLINE INDUSTRIES, INC.HUD9022026-04-02
10197344176441HUDSON RCIMEDLINE INDUSTRIES, INC.HUD9032026-04-02
10197344176458HUDSON RCIMEDLINE INDUSTRIES, INC.HUD9042026-04-02
10197344176465HUDSON RCIMEDLINE INDUSTRIES, INC.HUD9052026-04-02
10884521540514Newport MedicalNewport Medical Instruments, Inc.BCD20801P2018-09-07
10884521540521Newport MedicalNewport Medical Instruments, Inc.BCD22820P2018-09-20
10884521540545Newport MedicalNewport Medical Instruments, Inc.BCD23801P-EL2018-09-20
10884521540569Newport MedicalNewport Medical Instruments, Inc.BCD23811P2018-09-20
10884521540583Newport MedicalNewport Medical Instruments, Inc.BCD32820P2018-09-20
10884521540606Newport MedicalNewport Medical Instruments, Inc.BCD40801P2018-09-20
10884521540620Newport MedicalNewport Medical Instruments, Inc.BCD43801P2018-09-23
10884521540644Newport MedicalNewport Medical Instruments, Inc.BCD43801P-EL2018-09-20
10884521540668Newport MedicalNewport Medical Instruments, Inc.BCD43811P2018-09-20
10884521540699NewportNewport Medical Instruments, Inc.BCS12820P2022-02-28
10884521540705NewportNewport Medical Instruments, Inc.BCS22810P2022-02-28
10884521540712NewportNewport Medical Instruments, Inc.BCS22820P2022-02-28
10884521540736NewportNewport Medical Instruments, Inc.BCS32820P2022-02-28
14026704661203HUDSON RCITELEFLEX INCORPORATEDIPN0498142019-05-09
26923980108840N/AGaleMed Xiamen Co., Ltd.AB00902024-05-27
M996KC072GG0KC 072-GG - 22mm ID Reusable Ventilator TubingINSTRUMENTATION INDUSTRIES, INCORPORATEDKC 072-GG2017-04-14
M996KC072P220KC 072-P22 - Reusable Ventilator Tubing (15mm tube with 22mm ID cuffs)INSTRUMENTATION INDUSTRIES, INCORPORATEDKC 072-P222017-04-14
06923980112546MindrayGaleMed Xiamen Co., Ltd.XMR00662026-05-26
06923980112522MindrayGaleMed Xiamen Co., Ltd.XMR00112026-05-25
06923980112539MindrayGaleMed Xiamen Co., Ltd.XMR00122026-05-25
00619498392322ClimateLineAir 11 OxyRESMED PTY LTD392322025-08-04
07321820044658Vivo 1/2, Vivo 3Breas Medical AB0044652025-05-20
07321820067121Vivo 1/2, Vivo 3Breas Medical AB0067122025-05-20
07321820084265Vivo 1/2, Vivo 3Breas Medical AB0044652025-05-20
07321820084272Vivo 1/2, Vivo 3Breas Medical AB0067122025-05-20
07321820069903Vivo 1/2, Vivo 3Breas Medical AB0069902025-05-19
10197344043125HUDSON RCIMEDLINE INDUSTRIES, INC.HUD9012024-11-28
10197344043132HUDSON RCIMEDLINE INDUSTRIES, INC.HUD9002024-11-28
0503026704086522MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6MIntersurgical Incorporated51130182024-09-16
46923980108691MindrayGaleMed Xiamen Co., Ltd.XMR01272024-07-19
40026072022236EMAllied Medical, LLCL599-1902024-05-28
46923980108844N/AGaleMed Xiamen Co., Ltd.AB00902024-05-27
08500501360013BiWaze Cough Dual Lumen Circuit With MouthpieceAbmrc LLCBC233872024-04-01
08500501360020 BiWaze Cough Dual Lumen Circuit With Trach AdapterAbmrc LLCBC233942024-04-01
08500501360037BiWaze Cough Dual Lumen Circuit With Face Mask - ChildAbmrc LLCBC234002024-04-01
08500501360044BiWaze Cough Dual Lumen Circuit With Face Mask - Adult SmallAbmrc LLCBC234062024-04-01