FDA.reportPublic FDA data

Breathing mouthpiece, single-use

Definition
A device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). This is a single-use device.
GUDID devices
349
Last updated
2022-12-13 08:28:48

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05023323000491Clement Clarke InternationalCLEMENT CLARKE INTERNATIONAL LIMITED31220642022-12-05
05023323000507Clement Clarke InternationalCLEMENT CLARKE INTERNATIONAL LIMITED31220632022-12-05
05023323001085Clement Clarke InternationalCLEMENT CLARKE INTERNATIONAL LIMITED31220612022-12-05
05023323001191Clement Clarke InternationalCLEMENT CLARKE INTERNATIONAL LIMITED31220652022-12-05
05023323001344Clement Clarke InternationalCLEMENT CLARKE INTERNATIONAL LIMITED31220662022-12-05
05023323001559Clement Clarke InternationalCLEMENT CLARKE INTERNATIONAL LIMITED31220622022-12-05
05023323029492Clement Clarke InternationalCLEMENT CLARKE INTERNATIONAL LIMITED31221202022-12-05
B279F06070501Astraguard S D I DIAGNOSTICS INCAir 2022-06-20
B279F06071002Astraguard S D I DIAGNOSTICS INCAir 2022-06-20
B279S29310705001Astraguard S D I DIAGNOSTICS INCAir 2022-06-20
B279S2931071002Astraguard S D I DIAGNOSTICS INCAir 2022-06-20
00850022357718Insta/Vent - Safe-T-Shield MouthpieceMedi/Nuclear Corporation, Inc.MNMP500-NC2022-04-18
00817081027204Breathebite MouthpieceA-M SYSTEMS, LLCBreathebite Mouthpiece - 1649512022-01-19
04250972300202ScoutTubeGanshorn Medizin Electronic GmbH0194206202021-11-30
05030267004317MOUTHPIECE, 22FINTERSURGICAL INCORPORATED19310002021-10-25
05030267120512NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15FINTERSURGICAL INCORPORATED19380002021-10-13
05030267137749NIV ANGLED MOUTHPIECE WITH NOTCH 15MINTERSURGICAL INCORPORATED19370002021-10-13
05030267004249MOUTHPIECE, 22MINTERSURGICAL INCORPORATED19300002021-10-12
00817081027099Pulmonary Sample Kit, Disposable Rubber MouthpieceA-M SYSTEMS, LLCDisposable Rubber Mouthpiece Sample Kit - 1800492021-10-06
00817081027044Breathbite Mouthpiece, Disposable , Tongue DepressingA-M SYSTEMS, LLCBreathbite Mouthpiece - 1649502021-08-30
00840117319905Resp-O2 Cardboard Peak Flow MouthpieceDYNAREX CORPORATION361172021-04-22
00840117319912Resp-O2 Cardboard Peak Flow MouthpieceDYNAREX CORPORATION361182021-04-22
05099169285514PFTVITALOGRAPH (IRELAND) LIMITED28202020-06-21
05099169297722Safe-T-WayVITALOGRAPH (IRELAND) LIMITED20242020-06-21
55099169203100MouthpieceVITALOGRAPH (IRELAND) LIMITED20202020-06-21
55099169285533PFTVITALOGRAPH (IRELAND) LIMITED28202020-06-21
14719874690097POCKET AIRMICROBASE TECHNOLOGY CORP.MBPN002072020-06-03
10612479240114McKessonMCKESSON MEDICAL-SURGICAL INC.7892020-04-24
10612479240121McKessonMCKESSON MEDICAL-SURGICAL INC.7902020-04-24
10612479240138McKessonMCKESSON MEDICAL-SURGICAL INC.141-5050-502020-04-24
10612479240145McKessonMCKESSON MEDICAL-SURGICAL INC.141-5050-2002020-04-24
00817081023565Mouthpiece, Disposable, 7/8" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 7/8" O.D., 2.625" L - 1622002020-01-02
00817081023602Mouthpiece, Disposable, 1.0" OD, 2.625" LA-M SYSTEMS, LLCMouthpiece, 1.0" OD, 2.625" L - 1623002020-01-02
00817081023626Mouthpiece, Disposable, 1.0" OD, 2.625" LA-M SYSTEMS, LLCMouthpiece, 1.0" OD, 2.625" L - 1623022020-01-02
00817081023640Mouthpiece, Disposable, 1-1/16" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-1/16" O.D., 2.625" L - 1624002020-01-03
00817081023664Mouthpiece, Disposable, 1-1/16" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-1/16" O.D., 2.625" L - 1624022020-01-03
00817081023688Mouthpiece, Disposable, 1-1/8" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-1/8" O.D., 2.625" L - 1625002020-01-03
00817081023725Mouthpiece, Disposable, 1-1/8" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-1/8" O.D., 2.625" L - 1625022020-01-03
00817081023749Mouthpiece, Disposable, 1-3/16" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-3/16" O.D., 2.625" L - 1626002020-01-03
00817081023763Mouthpiece, Disposable, 1-3/16" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-3/16" O.D., 2.625" L - 1626022020-01-03
00817081023787Mouthpiece, Disposable, 1-5/16" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-5/16" O.D., 2.625" L - 1627002020-01-03
00817081023800Mouthpiece, Disposable, 1-5/16" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-5/16" O.D., 2.625" L - 1627022020-01-03
00817081023824Mouthpiece, Disposable, 1-3/8" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-3/8" O.D., 2.625" L - 1628002020-01-03
00817081023848Mouthpiece, Disposable, 1-3/8" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1-3/8" O.D., 2.625" L - 1628022020-01-03
00817081023862Mouthpiece, Disposable Flex, 1-3/8" OD, 2.625" LA-M SYSTEMS, LLCMouthpiece, Flex, 1-3/8" OD, 2.625" L - 1628032020-01-03
00817081024029Mouthpiece, Disposable, IPPB Plastic, 22MM OD, 18 MM IDA-M SYSTEMS, LLCMouthpiece, IPPB, 22MM OD-18 MM ID - 1634012020-01-13
00817081024043Mouthpiece, Disposable,Pediatric, VBMax AdapterA-M SYSTEMS, LLCMouthpiece, Pediatric, Adapter - 1634202020-01-13
00817081024067Mouthpiece, Disposable, 1.035" O.D., 2.625" LengthA-M SYSTEMS, LLCMouthpiece,1.035" O.D., 2.625" L - 1635002020-01-13
00817081024081Mouthpiece, Disposable, 1.035" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece, 1.035" O.D., 2.625" L - 1635022020-01-13
00817081024104Mouthpiece, Disposable, VitalorA-M SYSTEMS, LLCMouthpiece, Disposable, Vitalor - 1636002020-01-13
00817081024128Mouthpiece, Disposable, 1.045" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece,1.045" O.D., 2.625" L - 1637002020-01-13
00817081024142Mouthpiece, Disposable, 1.045" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece,1.045" O.D., 2.625" L - 1637022020-01-13
00817081024166Mouthpiece, Disposable, 1.058" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece,1.058" O.D., 2.625" L - 1638002020-01-13
00817081024180Mouthpiece, Disposable, 1.058" O.D., 2.625" LA-M SYSTEMS, LLCMouthpiece,1.058" O.D., 2.625" L - 1638022020-01-13
00817081024203Mouthpiece, Disposable, White, ThermoplasticA-M SYSTEMS, LLCMouthpiece, White, Thermoplastic - 1649102020-01-13
00817081024234Mouthseal, Disposable, White Thermoplastic RubberA-M SYSTEMS, LLCMouthseal, White Thermoplastic - 1650002020-01-13
00817081024258Mouthseal, Disposable, Blue Thermoplastic RubberA-M SYSTEMS, LLCMouthseal,Blue Thermoplastic Rubber - 1651002020-01-13
00817081024272Mouthseal, Disposable, Blue Thermoplastic IPPBA-M SYSTEMS, LLCMouthseal,Blue Thermoplastic IPPB - 1652002020-01-13
00817081024296Mouthseal, Disposable, White Thermoplastic IPPBA-M SYSTEMS, LLCMouthseal, White Thermoplastic IPPB - 1654002020-01-13
00817081024319Mouthpiece, Disposable, Flow SensorA-M SYSTEMS, LLCMouthpiece, Disposable, Flow Sensor - 1656002020-01-13
00817081024333Mouthpiece, Disposable For SP-150 SensorA-M SYSTEMS, LLCMouthpiece, Disposable For SP-150 Sensor - 1657002020-01-13
00817081024357Flow Sensor, Smart SenseA-M SYSTEMS, LLCFlow Sensor, Smart Sense - 1657252020-01-13
00817081024395Flow Tube, Easy One Air, DisposableA-M SYSTEMS, LLCFlow Tube, Easy One Air, - 1657502020-01-14
00817081024418Flow Tube, Easy One Air, DisposableA-M SYSTEMS, LLCFlow Tube, Easy One Air - 1657602020-01-14
00817081024432ndd Spirette Breathing TubeA-M SYSTEMS, LLCndd Spirette Breathing Tube - 1658502020-01-14
00817081024456ndd Spirette Breathing TubeA-M SYSTEMS, LLCndd Spirette Breathing Tube - 1658602020-01-14
00817081024470Mouthpiece, Disposable, Flow SensorA-M SYSTEMS, LLCMouthpiece, Disposable, Flow Sensor - 1659002020-01-14
00817081024494Mouthpiece, Disposable, 1.125" ID, 2.5" LA-M SYSTEMS, LLCMouthpiece, 1.125" ID, 2.5" L - 1682002020-01-14
00817081024517Mouthpiece, Disposable, 1.125" ID, 2.5" LA-M SYSTEMS, LLCMouthpiece, Disposable, 1.125" ID, 2.5" L - 1682022020-01-14
00817081024531Mouthpiece, Disposable, .900"OD, 2.50" L Assess SmallA-M SYSTEMS, LLCMouthpiece, Disposable, .900"OD, 2.50" L - 1683002020-01-14
00817081024555Mouthpiece, Disposable, .900"OD, 2.50" LA-M SYSTEMS, LLCMouthpiece, Disposable, .900"OD, 2.50" L - 1683022020-01-14
00817081024579Mouthpiece, Disposable, .875"OD, 2.50" LA-M SYSTEMS, LLCMouthpiece, Disposable, .875"OD, 2.50" L - 1683822020-01-14
34026704390107HUDSON RCITELEFLEX INCORPORATEDIPN0444282018-09-15
14026704594853HUDSON RCITELEFLEX INCORPORATEDIPN0425952020-01-29
34250892980196Micro MedicalCAREFUSION U.K. 232 LIMITED36-SST10002017-04-06
34250892980202Micro MedicalCAREFUSION U.K. 232 LIMITED36-SST12502017-04-06
34250892980219Micro MedicalCAREFUSION U.K. 232 LIMITED36-PSA10002017-04-06
34250892980226Micro MedicalCAREFUSION U.K. 232 LIMITED36-PSA12002017-04-06
B279F03600501mouthpieceS D I DIAGNOSTICS INCAccurette 2020-02-14
B279F03602002mouthpieceS D I DIAGNOSTICS INCAccurette 2020-02-14