FDA.reportPublic FDA data

mouthpiece

Primary DI
B279F03602002
Brand
mouthpiece
Company
S D I DIAGNOSTICS INC
Model
Accurette
Catalog number
F0360-200
Published
2020-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BYPMouthpiece, Breathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B279F0360200PrimaryHIBCC0
B279F03602002Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037690120
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06420099000264M9242-100, SpiroSafe Disposable Flow TransducerMedikro OyBYP2026-04-21
06420099000318703419 Disposable Flow Transducer QTY 100Medikro OyBYP2026-04-21
06420099000325703418 Disposable Flow Transducer QTY 25Medikro OyBYP2026-04-21
06420099000332703417 Disposable Flow Transducer QTY 4Medikro OyBYP2026-04-21
06420099000622M9242-SP-90, SpiroSafe Disposable Flow TransducerMedikro OyBYP2026-04-21
08904461055031OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
08904461055024OSSEOUS-SnorOFFEON MEDITECH PRIVATE LIMITEDBYP2026-03-13
06923980103674N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
46923980103672N/AGaleMed Xiamen Co., Ltd.BYP2025-12-23
10197344011315HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
20197344011312HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2025-08-18
14250892907373JaegerJaeger Medical GmbHBYP2025-06-02
14250892908080JaegerJaeger Medical GmbHBYP2025-06-02
34250892907360JaegerJaeger Medical GmbHBYP2025-06-02
10889483573457AirLife™AIRLIFEBYP2025-03-27
10889483569160AirLife™AIRLIFEBYP2025-03-18
10889483569191AirLife™AIRLIFEBYP2025-03-18
00817081028225Mouthpiece, Disposable, White, Thermoplastic, Bite Block StyleA-M SYSTEMS, LLCBYP2025-02-21
00817081028249Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue DepressingA-M SYSTEMS, LLCBYP2025-02-21
07613365500127SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500141SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
07613365500202SpiroDefGanshorn Medizin Electronic GmbHBYP2024-12-20
20197344120342HUDSON RCIMEDLINE INDUSTRIES, INC.BYP2024-12-10
04719873130191Aerogen®GoHCMED INNOVATIONS CO., LTD.BYP2024-08-20
20197344103734MEDLINEMEDLINE INDUSTRIES, INC.BYP2024-07-22
B279F0370050Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279F0370200Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S298070050Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
B279S298070200Air Tube S D I DIAGNOSTICS INCBYP2024-04-08
00384620000733InFloConeALLIANCE TECH MEDICAL INCBYP2023-09-08