FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXII
DI: B9671504000
·
Model: MAXII
·
Aei Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MAXII
- Primary DI
- B9671504000
- Version / Model
- MAXII
- Catalog Number
- 150400
- Company Name
- Aei Technologies, Inc.
- Labeler DUNS
- 961851326
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-03
- Public Version
- 1
- Public Version Date
- 2021-11-11
- Public Version Status
- New
- Public Device Record Key
- 4fda0fcd-2727-4ce6-8d7f-feb3ff29bed1
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 | B9671504000 | HIBCC |
Customer Contacts
- Phone
- +1-630-548-3545
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922660 | 000 |