FDA.report

Pulmonary function testing filter/mouthpiece

Definition
A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.
GUDID devices
517
Last updated
2026-01-08 15:01:45

Related Product Codes

CodeDeviceSpecialtyClassDevices
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2259
BZGSpirometer, DiagnosticAnesthesiology2241
BYPMouthpiece, BreathingAnesthesiology113
JAXPneumotachometerAnesthesiology22
MXASystem, Test, Breath Nitric OxideClinical Toxicology22

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
20889483229740BlockAide™SUNMED, LLC6901-1E2025-12-31
20889483229757BlockAide™SUNMED, LLC6901-1R2025-12-19
20889483229795BlockAide™SUNMED, LLC6902-2E2025-12-19
20889483229801BlockAide™SUNMED, LLC6902-2R2025-12-19
20889483229818BlockAide™SUNMED, LLC6903-3E2025-12-19
20889483229825BlockAide™SUNMED, LLC6903-3R2025-12-19
20889483229832BlockAide™SUNMED, LLC6904-4E2025-12-19
20889483229849BlockAide™SUNMED, LLC6904-4R2025-12-19
20889483229856BlockAide™SUNMED, LLC6905-5E2025-12-19
20889483229863BlockAide™SUNMED, LLC6905-5R2025-12-19
20889483229870BlockAide™SUNMED, LLC6906-6E2025-12-19
20889483229887BlockAide™SUNMED, LLC6906-6R2025-12-19
00817081028553VBMax28s, PF Testing Filter Labeled DR BurtonA-M SYSTEMS, LLCVBMax28s, DR Burton - VBMax28s2025-08-07
00817081028577VBMax28e, PF Testing Filter Labeled DR BurtonA-M SYSTEMS, LLCVBMax28e, DR Burton - VBMax28e2025-08-07
00817081028515VBMAX34, DISPOSABLE PF TESTING FILTERA-M SYSTEMS, LLCVBMAX34 - 1564002025-06-25
00817081028492VBMax34, PF Testing Filter Labeled DR BurtonA-M SYSTEMS, LLCVBMax34, PF Testing Filter - 1564042025-06-03
00817081028416VBMax28, PF Testing FilterA-M SYSTEMS, LLCVBMax28, PF Testing Filter - 1569042025-04-03
00817081028171VBMax35E, PF Testing FilterA-M SYSTEMS, LLCVBMax35E, PF Testing Filter - 1465042025-02-14
00817081028072VBMax35s, PF Testing Filter Labeled DR BurtonA-M SYSTEMS, LLCVBMax35s, DR Burton - 1365042025-02-13
00817081028096VBMax35, PF Testing FilterA-M SYSTEMS, LLCVBMax35, PF Testing Filter - 1565052025-02-13
00817081028119VBMax36S, PF Testing Filter Labeled DR BurtonA-M SYSTEMS, LLCVBMax36S, PF Testing Filter - 1366042025-02-13
00817081028133VBMax36E, PF Testing FilterA-M SYSTEMS, LLCVBMax36E, PF Testing Filter - 1466042025-02-13
00817081028157VBMax36, PF Testing FilterA-M SYSTEMS, LLCVBMax36, PF Testing Filter - 1566042025-02-13
00817081027976VBMax30E, PF Testing FilterA-M SYSTEMS, LLCVBMax30E - 1463042025-01-27
00817081027990VBMax30, PF Testing FilterA-M SYSTEMS, LLCVBMax30 - 1563052025-01-27
00817081028010VBMax34S, PF Testing Filter Labeled DR BurtonA-M SYSTEMS, LLCVBMax34S - 1364042025-01-27
00817081028034VBMax34E, PF Testing Filter Labeled DR BurtonA-M SYSTEMS, LLCVBMax34E - 1464042025-01-27
07613365500110SpiroDefGanshorn Medizin Electronic GmbHA2024-12-20
07613365500134SpiroDefGanshorn Medizin Electronic GmbHA2024-12-20
07613365500196SpiroDefGanshorn Medizin Electronic GmbHA2024-12-20
10197344103737MEDLINEMEDLINE INDUSTRIES, INC.DYNJ8542024-07-22
50885403293274AirLifeCarefusion Corporation5097PF2016-09-21
B279F060930002PulmoguardS D I DIAGNOSTICS INCV2024-03-13
B279S293201200PulmoguardS D I DIAGNOSTICS INCA2024-03-13
F0660200PulmoguardS D I DIAGNOSTICS INCA2024-03-13
03760253450638ErgofilterFIM MEDICALSP12023-09-04
03760253450645ErgofilterFIM MEDICALSP1M2023-09-04
B279F063908001PulmoguardS D I DIAGNOSTICS INCV2023-08-22
07640142190646spirette FA Pro/LABNDD Medizintechnik AG2050-732023-06-23
07640142190677spirette mNDD Medizintechnik AG2050-72023-06-23
07640142190462EasyOne FlowTubeNDD Medizintechnik AG5050-5002023-06-22
07640142190486spiretteNDD Medizintechnik AG2050-102023-06-22
07640142190516EasyOne FlowTubeNDD Medizintechnik AG5050-2002023-06-22
07640142190561Filter Adapter SPNDD Medizintechnik AG2030-112023-06-22
07640142190578Filter Adapter FTNDD Medizintechnik AG2030-212023-06-22
00817081027488VBMax28, Disposable PF Testing FilterA-M SYSTEMS, LLCVBMax28 - 1569002023-02-09
B279F06090501PulmoguardS D I DIAGNOSTICS INCV2022-12-06
B279S2931090501PulmoguardS D I DIAGNOSTICS INCV2022-12-06
05030267160570PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECEIntersurgical Incorporated16910072022-07-15
05030267160594PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECEIntersurgical Incorporated16910062022-07-15
05030267160648PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECEIntersurgical Incorporated16910052022-07-15
05030267161027PULMO-PROTECT LUNG FUNCTION FILTER WITH INTEGRATED MOUTHPIECEIntersurgical Incorporated16910042022-07-15
20193489000310MedlineMEDLINE INDUSTRIES, INC.DYNJ756BMN2022-06-10
00817081027280ViroMaxA-M SYSTEMS, LLCViroMax - 1562192022-05-12
B446756W0POLYTECH FILTERPOLYTECHNIC RESOURCES INC756W2021-10-25
05030267136223FLEXIBLE MOUTHPIECEINTERSURGICAL INCORPORATED16910202021-10-12
B446M100780E20Polytech FilterPOLYTECHNIC RESOURCES INCM100780E22021-08-23
10888277629547MedlineMEDLINE INDUSTRIES, INC.DYNJ756ELB2021-07-14
20888277629551MedlineMEDLINE INDUSTRIES, INC.DYNJ756NB2021-07-14
20888277652382MedlineMEDLINE INDUSTRIES, INC.DYNJ758B2021-07-14
20888277652429MedlineMEDLINE INDUSTRIES, INC.DYNJ759BMN2021-07-14
20888277652436MedlineMEDLINE INDUSTRIES, INC.DYNJ759ELB2021-07-14
20888277652450MedlineMEDLINE INDUSTRIES, INC.DYNJ760BMN2021-07-14
20888277652467MedlineMEDLINE INDUSTRIES, INC.DYNJ760ELB2021-07-14
00817081026948VBMax35 A-M SYSTEMS, LLCVBMax35 - 1565082021-06-16
B446S100757NW0Polytech FilterPOLYTECHNIC RESOURCES INCS100757NW2021-04-26
B446M100780EW0Polytech FilterPOLYTECHNIC RESOURCES INCM100780EW2021-02-22
B446M100780W0Polytech FilterPOLYTECHNIC RESOURCES INCM100780W2021-02-22
B446S100756EW0Polytech FilterPOLYTECHNIC RESOURCES INCS100756EW2021-02-22
B446S100756NW0Polytech FilterPOLYTECHNIC RESOURCES INCS100756NW2021-02-22
B446S100758EL0Polytech FilterPOLYTECHNIC RESOURCES INCS100758EL2021-02-22
B446S100758NK0Polytech FilterPOLYTECHNIC RESOURCES INCS100758NK2021-02-22
B446S100758NW0Polytech FilterPOLYTECHNIC RESOURCES INCS100758NW2021-02-22
B446S100759EW0Polytech FilterPOLYTECHNIC RESOURCES INCS100759EW2021-02-22
00817081026818VBMax34E, Disposable PF Testing FilterA-M SYSTEMS, LLCVBMax34E - 1464722020-08-27
00817081026795VBMax35EA-M SYSTEMS, LLCVBMax35E - 1465162020-08-18
00817081026771VBMaxA-M SYSTEMS, LLCVBMax35 - 1565162020-08-06
B446N1007540Polytech MouthpiecePOLYTECHNIC RESOURCES INCN1007542020-07-03
B279F06060501Pulmoguard S D I DIAGNOSTICS INCC2020-05-13
B279F06061002Pulmoguard S D I DIAGNOSTICS INCC2020-05-13