MGC Diagnsotics 536053-009

GUDID 00810016250623

GAS CO2 LINEARITY 21%O2, BAL N2

MEDICAL GRAPHICS CORPORATION

Pulmonary function analysis system, adult

• Primary Device ID: 00810016250623
• NIH Device Record Key: 7606f4e2-40cc-45e3-8c52-e878b6a3551b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MGC Diagnsotics
• Version Model Number: 536053-009
• Catalog Number: 536053-009
• Company DUNS: 094045622
• Company Name: MEDICAL GRAPHICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
GS1	00810016250623 [Primary]

FDA Product Code

• BXK: Gas, Calibration (Specified Concentration)

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: 2019-04-09
• Device Publish Date: 2019-04-01

On-Brand Devices [MGC Diagnsotics]

• 00810016251125: GAS CO2 LINEARITY 3%CO2, BAL N2
• 00810016251118: GAS CO2 LINEARITY 5%CO2, BAL N2
• 00810016250623: GAS CO2 LINEARITY 21%O2, BAL N2
• 00810016250838: PREVENT FLOW SENSOR, 24 PACK
• 00810016250050: Ultima System CPX - 230 UPS