FDA.reportPublic FDA data

MGC Diagnsotics

Primary DI
00810016250838
Brand
MGC Diagnsotics
Company
MEDICAL GRAPHICS CORPORATION
Model
758100-004
Catalog number
758100-004
Device description
PREVENT FLOW SENSOR, 24 PACK
Published
2019-02-22
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810016250838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016250838008100162508388100162508380810016250838

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
094045622
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810016250555Medical Graphics147999-0042023-07-18
00810016250579Medical Graphics147999-5022023-07-18
00810016250616Medical Graphics536018-001 2023-06-14
00810016250340MGC Diagnostics762042-003800704-0032019-02-22
00810016250357MGC Diagnostics762042-904800704-9042019-02-22
00810016250364MGC Diagnostics762042-905800704-9052019-02-22
B3687620420030MGC Diagnostics762042-003800704-0032017-01-12
B3687620429040MGC Diagnostics762042-904800704-9042018-06-18
B3687620429050MGC Diagnostics762042-905800704-9052018-06-18
B368700023905MGC Diagnostics700023-905700023-9052016-09-09
B3687000239060MGC Diagnostics700023-9062018-06-18
B368800810001MGC Diagnostics800810-001800810-0012016-09-09
B368800810011MGC Diagnostics800810-011800810-0112016-09-09
B3688008100210MGC Diagnostics800810-0212018-06-18
B3688008100310MGC Diganostics800810-0312018-06-18
B368800820001MGC Diagnostics800820-001800820-0012016-09-07
B368800820011MGC Diagnostics800820-011800820-0112016-09-09
B3688008200210MGC Diagnostics800820-0212018-06-18
B3688008200310MGC Diagnostics800820-0312018-06-18
B368800830001MGC Diagnostics800830-001800830-0012016-09-09

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
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
00874750006298N/AHANS RUDOLPH, INC.JAX2016-09-16