FDA.reportPublic FDA data

FloSense

Primary DI
B279DP2112
Brand
FloSense
Company
S D I DIAGNOSTICS INC
Model
kushion klip
Catalog number
DP211-2
Device description
FloSense Sensor
Published
2016-09-09
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
JAXPneumotachometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAXPneumotachometerAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990962000FLOSENSE, MODEL 29-8010Sdi Diagnostics, Inc.2000-01-07JAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B279DP2112PrimaryHIBCC0
DP21123Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037690120
Device count
250
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008171360265413830HANS RUDOLPH, INC.JAX2021-04-06
008171360263743830HANS RUDOLPH, INC.JAX2020-11-20
00850008733048Accutach Flow SensorB&B Medical TechnologiesJAX2019-07-18
008171360262208311 PNTHANS RUDOLPH, INC.JAX2019-07-18
00810016250814MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONJAX2019-03-31
00810016250821MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONJAX2019-03-31
00810016250838MGC DiagnsoticsMEDICAL GRAPHICS CORPORATIONJAX2019-02-22
008747500081319301 HAND CONTROLLERHANS RUDOLPH, INC.JAX2018-11-02
00817136025599n/aHANS RUDOLPH, INC.JAX2018-02-08
00817136025278n/aHANS RUDOLPH, INC.JAX2017-04-21
B279298010F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298010K1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298011FFloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298011KFloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298012F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298012K1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298020F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298020K1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298021F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
B279298021K1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
00817136025063n/aHANS RUDOLPH, INC.JAX2016-10-17
00874750006151n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006168n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006175n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006182N/AHANS RUDOLPH, INC.JAX2016-09-16
00874750006243n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006250n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006267n/aHANS RUDOLPH, INC.JAX2016-09-16
00874750006274N/AHANS RUDOLPH, INC.JAX2016-09-16
00874750006281N/AHANS RUDOLPH, INC.JAX2016-09-16