FDA.reportPublic FDA data

MGC Diagnostics

Primary DI
00810016250159
Brand
MGC Diagnostics
Company
MEDICAL GRAPHICS CORPORATION
Model
800840-011
Catalog number
800840-011
Device description
Ultima System CardiO2 - 120V UPS
Published
2019-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZLComputer, Oxygen-Uptake

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZLComputer, Oxygen-UptakeAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061731000MEDGRAPHICS ULTIMA SYSTEMMedical Graphics Corp.2006-09-06BZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B368800840011PreviousHIBCC0
00810016250159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016250159008100162501598100162501590810016250159

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary stress exercise monitoring systemAn assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results.

Regulatory Flags#

DUNS number
094045622
Device count
1
Serial number
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
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZL2026-04-15
B9671504140MAXIIaAei Technologies, Inc.BZL2025-01-27
00810445030001MicrolifeMICROLIFE USA, INC.BZL2023-06-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBZL2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyBZL2023-04-19
00195278524089NAGE Healthcare Finland OyBZL2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyBZL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyBZL2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyBZL2022-05-13
00840682104135NAGE Healthcare Finland OyBZL2022-03-07
00840682104302NAGE Healthcare Finland OyBZL2022-03-07
B6568100ReeVueKORR MEDICAL TECHNOLOGIES INC.BZL2022-03-03
B9671503000MOXUSAei Technologies, Inc.BZL2021-11-03
B9671504000MAXIIAei Technologies, Inc.BZL2021-11-03
00840682143806CARESCAPE B650GE Healthcare Finland OyBZL2020-03-11
00840682142380CARESCAPE B450GE Healthcare Finland OyBZL2020-03-09
00840682123433CARESCAPE RADGE Healthcare Finland OyBZL2020-03-05
00840682144308CARESCAPE B850GE Healthcare Finland OyBZL2020-03-05
00840682138147NAGE Healthcare Finland OyBZL2019-06-19
00840682138161NAGE Healthcare Finland OyBZL2019-06-19
00860001261509MediPines Gas Exchange MonitorMEDIPINES CORPORATIONBZL2019-03-25
00860001261516MediPines Single Patient Use Breathing CircuitMEDIPINES CORPORATIONBZL2019-03-25
00860001261530MediPines Gas Exchange Monitor Starter KitMEDIPINES CORPORATIONBZL2019-03-25
00810016250012MCG DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-23
00810016250111MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-23
00810016250081MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250005MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250029MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250036MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22
00810016250043MGC DiagnosticsMEDICAL GRAPHICS CORPORATIONBZL2019-02-22