FDA.reportPublic FDA data

Astraguard

Primary DI
B279F0301100
Brand
Astraguard
Company
S D I DIAGNOSTICS INC
Model
Klip
Catalog number
F0301-100
Device description
Astraguard Filter
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062913000ASTRAGUARD PULMONARY FUNCTION FILTERSdi Diagnostics, Inc.2007-01-26BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B279F0301100PrimaryHIBCC0
B279F03011002Unit 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
100
Kit
true
Lot or batch
true

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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Primary DI, Brand, Company table
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