MGC Diagnostics

GUDID B3688008300210

Ultima System PFX

MEDICAL GRAPHICS CORPORATION

Cardiopulmonary stress exercise monitoring system

• Primary Device ID: B3688008300210
• NIH Device Record Key: 24dab8b6-2396-49e2-8daf-1a6eafa570ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGC Diagnostics
• Version Model Number: 800830-021
• Company DUNS: 094045622
• Company Name: MEDICAL GRAPHICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3688008300210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061731

FDA Product Code

• BZL: Computer, Oxygen-Uptake

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-19
• Device Publish Date: 2018-06-18

On-Brand Devices [MGC Diagnostics]

• B368830008902: Elite Platinum DX
• B368830007902: Elite Platinum DL
• B368830005002: Elite Platinum DX
• B3688008600310: Ultima System PFX Cardio2 - 230V UPS
• B3688008600210: Ultima System PFX Cardio2
• B368800860011: Ultima System PFX Cardio2 - 120V UPS
• B368800860001: Ultima System PFX Cardio2
• B368800850001: Ultima System PFX Frontera
• B3688008400310: Ultima System Cardio2 - 230V UPS
• B3688008400210: Ultima System Cardio2
• B368800840011: Ultima System CardiO2 - 120V UPS
• B368800840001: Ultima System Cardio2
• B3688008300310: Ultima System PFX - 230V UPS
• B3688008300210: Ultima System PFX
• B368800830011: Ultima System PFX - 120V UPS
• B368800830001: Ultima System PFX
• B3688008200310: Ultima System PF - 230V UPS
• B3688008200210: Ultima System PF
• B368800820011: Ultima System PF - 120V UPS
• B368800820001: Ultima System PF
• B3688008100210: Ultima System CPX
• B368800810011: Ultima System CPX - 120V UPS
• B368800810001: Ultima System CPX
• B3687620429050: CPFS/D-USB
• B3687620429040: CPFS/D-USB
• B3687620420030: CPFS/D-USB
• B368700023905: Express CCM
• 536723004: FILTER KIT 4
• 536723001: FILTER KIT 2
• B368536719004: Filter Kit 3
• 536719001: FILTER KIT 1
• 536713004: PREVENT II FILTER OVAL LIP GUARD
• 536713003: FILTER FOR RESMON FOT-OVAL MOUTHPIECE
• 536713002: FILTER FOR PREVENT FLOW SENSOR-OVAL
• B3685367130010: preVent Filter
• 00810016250821: DIRECTCONNECT FLOW SENSOR - KEYED
• 00810016250814: DIRECTCONNECT FLOW SENSOR NON-KEYED
• 00810016251606: GAS HAST 15%O2, BAL N2
• 00810016251583: GAS REFERENCE 21%O2, BAL N2
• 00810016251569: GAS CALIBRATION 5%CO2, 12%O2, BAL N2
• 00810016251552: GAS DLCO (RTD) 0.3%CO, 0.3%CH4, 21%O2, BAL N2
• 00810016251538: GAS COMPRESSED AIR
• 00810016251514: GAS CO2 LINEARITY 10%CO2, 35%O2, BAL N2
• 00810016251491: GAS CO2 LINEARITY 7%CO2, 16%O2, BAL N2
• 00810016251477: GAS OXYGEN 99.95%O2
• 00810016251460: GAS NICO 4%CO2, 35%O2, BAL N2
• 00810016251446: GAS NITROGEN 99.95%N2
• 00810016251439: GAS DLCO RTD LINEARITY 0.13%CO, 0.16%CH4, 5%CO2, 17%O2, BAL N2
• 00810016251422: GAS DLCO RTD LINEARITY 0.30%CO, 0.30%CH4, 21%O2, BAL N2
• 00810016251415: GAS DLCO RTD LINEARITY 0.35%CO, 0.35%CH4, 21%O2, BAL N2