FDA.reportPublic FDA data

Accutach Flow Sensor

Primary DI
00850008733048
Brand
Accutach Flow Sensor
Company
B&B Medical Technologies
Model
25250
Catalog number
25250
Device description
Pneumotach Adult Flow Sensor, 50 units
Published
2019-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JAXPneumotachometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAXPneumotachometerAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K770061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K770061000VO RESPIRATORY PNEUMOTACHOGRAPHResearch Development Corp.1977-01-14JAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008733048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008733048008500087330488500087330480850008733048

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-flow sensor, reusableA device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
829743579
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008733147ET Tape 11025110252023-07-06
00850008733154ET Tape 11020110202023-07-06
00850008733208BODAI NEO2-SAFE11105111052023-07-06
00850008733215BODAI NEO2-SAFE11100111002023-07-06
00850008733260Baby Tape Plus25395253952023-07-06
00850008733277Baby Tape Plus25390253902023-07-06
00850008733185Trachstay11270112702020-03-24
00850008733130Locktite11090110902020-01-29
00850008733093Trachguard11250112502020-01-20
00850008733109Trachguard11255112552020-01-20
00850008733116ET Tape II11015110152020-01-20
00850008733123ET Tape II11010110102020-01-20
00850008733086Universal Bite Block, Adult11160111602019-12-13
00850008733062Stabiltube11060110602019-11-08
00850008733079Stabiltube11065110652019-11-08
00850008733031B&B Bubbler25312253122019-07-12
00850008733055B&B Bubbler25324253242019-07-12
00850008733024HOPE Nebulizer11310113102019-05-17
00850008733000HOPE Nebulizer - Adult Kit11320113202019-05-13
00850008733017HOPE Nebulizer - Pediatric Kit11330113302019-05-13

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Primary DI, Brand, Company table
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008171360265413830HANS RUDOLPH, INC.JAX2021-04-06
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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
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B279298010F1FloSenseS D I DIAGNOSTICS INCJAX2017-02-11
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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
00874750006298N/AHANS RUDOLPH, INC.JAX2016-09-16