FDA.reportPublic FDA data

Mouthpiece

Primary DI
B279DP400100
Brand
Mouthpiece
Company
S D I DIAGNOSTICS INC
Model
Sense
Catalog number
DP400-025
Device description
Mouthpiece
Published
2016-09-20
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
false

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150515000IQSense Flow Sensor MouthpieceSdi Diagnostics, Inc.2016-01-12BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B279DP400100PackageHIBCC25In Commercial Distribution
B279DP400025PrimaryHIBCC0
B279DP4000251Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, reusableA 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. The device is typically attached, either directly or through other tubes/adapters, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037690120
Device count
25
DM exempt
false
Premarket exempt
false
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

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