MGC Diagnostics

GUDID 00810016251217

PREVENT II FILTER-ROUND-TEAL

MEDICAL GRAPHICS CORPORATION

Pulmonary function testing filter/mouthpiece
Primary Device ID00810016251217
NIH Device Record Keya97a9ff7-862c-4c89-9680-4011962f0495
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGC Diagnostics
Version Model Number536756-NT
Company DUNS094045622
Company NameMEDICAL GRAPHICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810016251217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-10
Device Publish Date2019-06-01

On-Brand Devices [MGC Diagnostics]

B368830008902Elite Platinum DX
B368830007902Elite Platinum DL
B368830005002Elite Platinum DX
B3688008600310Ultima System PFX Cardio2 - 230V UPS
B3688008600210Ultima System PFX Cardio2
B368800860011Ultima System PFX Cardio2 - 120V UPS
B368800860001Ultima System PFX Cardio2
B368800850001Ultima System PFX Frontera
B3688008400310Ultima System Cardio2 - 230V UPS
B3688008400210Ultima System Cardio2
B368800840011Ultima System CardiO2 - 120V UPS
B368800840001Ultima System Cardio2
B3688008300310Ultima System PFX - 230V UPS
B3688008300210Ultima System PFX
B368800830011Ultima System PFX - 120V UPS
B368800830001Ultima System PFX
B3688008200310Ultima System PF - 230V UPS
B3688008200210Ultima System PF
B368800820011Ultima System PF - 120V UPS
B368800820001Ultima System PF
B3688008100210Ultima System CPX
B368800810011Ultima System CPX - 120V UPS
B368800810001Ultima System CPX
B3687620429050CPFS/D-USB
B3687620429040CPFS/D-USB
B3687620420030CPFS/D-USB
B368700023905Express CCM
536723004FILTER KIT 4
536723001FILTER KIT 2
B368536719004Filter Kit 3
536719001FILTER KIT 1
536713004PREVENT II FILTER OVAL LIP GUARD
536713003FILTER FOR RESMON FOT-OVAL MOUTHPIECE
536713002FILTER FOR PREVENT FLOW SENSOR-OVAL
B3685367130010preVent Filter
00810016250821DIRECTCONNECT FLOW SENSOR - KEYED
00810016250814DIRECTCONNECT FLOW SENSOR NON-KEYED
00810016251606GAS HAST 15%O2, BAL N2
00810016251583GAS REFERENCE 21%O2, BAL N2
00810016251569GAS CALIBRATION 5%CO2, 12%O2, BAL N2
00810016251552GAS DLCO (RTD) 0.3%CO, 0.3%CH4, 21%O2, BAL N2
00810016251538GAS COMPRESSED AIR
00810016251514GAS CO2 LINEARITY 10%CO2, 35%O2, BAL N2
00810016251491GAS CO2 LINEARITY 7%CO2, 16%O2, BAL N2
00810016251477GAS OXYGEN 99.95%O2
00810016251460GAS NICO 4%CO2, 35%O2, BAL N2
00810016251446GAS NITROGEN 99.95%N2
00810016251439GAS DLCO RTD LINEARITY 0.13%CO, 0.16%CH4, 5%CO2, 17%O2, BAL N2
00810016251422GAS DLCO RTD LINEARITY 0.30%CO, 0.30%CH4, 21%O2, BAL N2
00810016251415GAS DLCO RTD LINEARITY 0.35%CO, 0.35%CH4, 21%O2, BAL N2

Trademark Results [MGC Diagnostics]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MGC DIAGNOSTICS
MGC DIAGNOSTICS
76712890 4398127 Live/Registered
MGC Diagnostics Corporation
2012-11-19
MGC DIAGNOSTICS
MGC DIAGNOSTICS
76712886 4394255 Live/Registered
MGC Diagnostics Corporation
2012-11-19
MGC DIAGNOSTICS
MGC DIAGNOSTICS
76711697 4307099 Live/Registered
MGC DIAGNOSTICS CORPORATION
2012-06-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.