FDA.reportPublic FDA data

Pulmoguard

Primary DI
B279S293106050
Brand
Pulmoguard
Company
S D I DIAGNOSTICS INC
Model
C
Catalog number
29-3106-050
Device description
Filtrette Air PG
Published
2020-05-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934509000PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTERSdi Diagnostics, Inc.1993-10-21CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B279S293106050PrimaryHIBCC0
B279S2931060501Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function testing filter/mouthpieceA 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.

Regulatory Flags#

DUNS number
037690120
Device count
50

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B279F0317M050Filtrette A with Mini MouthpieceFiltrette A with Mini MouthpieceF0317M-0502025-10-24
B279F0320M050Filtrette with Mini MouthpieceFiltrette with Mini MouthpieceF0320M-0502025-10-24
B279M7025Mini MouthpieceMini MouthpieceM70252025-10-24
B279S297910M050Filtrette with Mini MouthpieceFiltrette with Mini Mouthpiece29-7910M-0502025-10-24
B279S297917050Filtrette A with Mini MouthpieceFiltrette A with Mini Mouthpiece29-7917M-0502025-10-24
B279S293025Mini MouthpieceMini Mouthpiece29-30252025-10-23
B279F0370050Air Tube ATF0370-0502024-04-08
B279F0370200Air Tube ATF0370-2002024-04-08
B279F0661050PulmoguardAF0661-0502024-04-08
B279S293301050PulmoguardA29-3301-0502024-04-08
B279S298070050Air Tube AT29-8070-0502024-04-08
B279S298070200Air Tube AT29-8070-2002024-04-08
B279F037005001Air Tube ATF0370-0502024-04-08
B279F037020002Air Tube ATF0370-2002024-04-08
B279F066105001PulmoguardAF0661-0502024-04-08
B279S29330105001PulmoguardA29-3301-0502024-04-08
B279S29807005001Air Tube AT29-8070-0502024-04-08
B279S29807020002Air Tube AT29-8070-2002024-04-08
B279F0609300PulmoguardVF0609-3002024-03-13
B279F0660050PulmoguardAF0660-0502024-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10193489339826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAH2022-08-04
10193489139990MedlineMEDLINE INDUSTRIES, INC.CAH2022-08-03
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
10193489019452HYDRO-GUARD MINI BREATHING FILTER Intersurgical IncorporatedCAH2021-10-05
10190752141834AirLife™VYAIRE MEDICAL, INC.CAH2021-04-09
10190752136434Vital Signs™Vyaire GmbHCAH2021-04-02
10190752139589Vital Signs™AirLife Finland OyCAH2021-04-02
10190752135987Vital Signs™AirLife Finland OyCAH2021-03-05
10190752135994Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136632Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136793Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136809Vital Signs™AirLife Finland OyCAH2021-03-05
10190752138094Vital Signs™VYAIRE MEDICAL, INC.CAH2021-03-05
10190752139107Vital Signs™AirLife Finland OyCAH2021-03-05
10190752139558Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140080Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140097AirLife™AirLife Finland OyCAH2021-03-05
10190752136724Vital SignsAirLife Finland OyCAH2021-03-01
10190752147171AirLife™AIRLIFECAH2020-02-04
10190752147188AirLife™VYAIRE MEDICAL, INC.CAH2020-02-04