FDA.reportPublic FDA data

MAXII

Primary DI
B9671504000
Brand
MAXII
Company
Aei Technologies, Inc.
Model
MAXII
Catalog number
150400
Device description
Metabolic Measurement System
Published
2021-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K922660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922660000PHYSIO-DYNE EASI - LABPhysio-Dyne1993-04-08BZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B9671504000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic measurement trolleyA cart designed to accommodate equipment necessary to measure metabolic energy expenditure. This may also include cardiovascular and respiratory function measurements when the patient is at rest and/or during exercise. This trolley (cart) will typically hold devices such as oxygen (O2) and carbon dioxide (CO2) analysers, airflow measurement devices, controls and a computer system that processes the measurements and provides the required information. It will typically be used to assess the status of patients in the intensive care unit (ICU), burn treatment unit, and accident and emergency (A&E) unit.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-630-548-3545info@aeitechnologies.com

Regulatory Flags#

DUNS number
961851326
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B9671502000CD3ACD3A1502002021-11-03
B9671504140MAXIIaMAXIIa1504142025-01-27
B9671501000S3AS3A1501002021-11-03
B9671503000MOXUSMOXUS1503002021-11-03

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
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
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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
00810016250159MGC 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