MGC Diagnostics 800860-001

GUDID B368800860001

Ultima System PFX Cardio2

MEDICAL GRAPHICS CORPORATION

Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system Cardiopulmonary stress exercise monitoring system

• Primary Device ID: B368800860001
• NIH Device Record Key: 4e417b95-088a-4346-8c3d-47e2fc0a965b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGC Diagnostics
• Version Model Number: 800860-001
• Catalog Number: 800860-001
• 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	B368800860001 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

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