MAXIIa

Basic Information

• Brand Name: MAXIIa
• Primary DI: B9671504140
• Version / Model: MAXIIa
• Catalog Number: 150414
• Company Name: Aei Technologies, Inc.
• Labeler DUNS: 961851326
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-27
• Public Version: 1
• Public Version Date: 2025-02-04
• Public Version Status: New
• Public Device Record Key: 91f8384b-e7bc-4418-b2a6-90bc99be652f

Device Description

Metabolic Measurement System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZL	Computer, Oxygen-Uptake	Anesthesiology	868.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10297	Metabolic measurement trolley	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B9671504140	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K922660	000