MaxO2+ A Medical

Basic Information

• Brand Name: MaxO2+ A Medical
• Primary DI: 00853061006982
• Version / Model: R217P62
• Company Name: MAXTEC, LLC
• Labeler DUNS: 169911828
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ca2127ac-864d-415f-b207-ea8665abcf43

Device Description

Oxygen Analyzer

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: Yes
• 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
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	868.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35219	Respiratory oxygen monitor, line-powered	A mains electricity (AC-powered) instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range; it may also include appropriate temperature-compensated electrodes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853061006982	GS1

Premarket Submissions

Submission Number	Supplement Number
K040484	000