AccessGUDID - DEVICE: MAXII (B9671504000)

GUDID

Device Identifier (DI) Information

Brand Name: MAXII
Version or Model: MAXII
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 150400
Company Name: Aei Technologies, Inc.

Primary DI Number: B9671504000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961851326 *Terms of Use

Device Description: Metabolic Measurement System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZL	Computer, Oxygen-Uptake

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922660	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4fda0fcd-2727-4ce6-8d7f-feb3ff29bed1
Public Version Date: November 11, 2021
Public Version Number: 1
DI Record Publish Date: November 03, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1-630-548-3545
Email: info@aeitechnologies.com

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