FDA.reportPublic FDA data

MGC Diagnostics

Primary DI
00810016250814
Brand
MGC Diagnostics
Company
MEDICAL GRAPHICS CORPORATION
Model
750050-003
Catalog number
750050-003
Device description
DIRECTCONNECT FLOW SENSOR NON-KEYED
Published
2019-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00810016250814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016250814008100162508148100162508140810016250814

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function testing filter/mouthpieceA non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.

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