Ultramaxo2 Oxygen Analyer
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Maxtec, Llc
Identity
- Trade Name
- UltraMax O2 Oxygen Analyzer EUDAMEDUltraMax FDA UDIULTRAMAXO2 FDA UDI
- Generic Name
- Respiratory oxygen monitor, battery-powered FDA UDI
- Device Name
- UltraMax O2 Oxygen Analyzer EUDAMEDOXYGEN ANALYZER, ULTRAMAX FDA UDIAnalyzer (Turkey) FDA UDI
- Model / Reference
- R221P11 EUDAMEDFDA UDIR221P11-002 EUDAMEDFDA UDI
- Description
- OXYGEN ANALYZER, ULTRAMAX FDA UDIAnalyzer (Turkey) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817770020929 EUDAMEDFDA UDI00817770020998 EUDAMEDFDA UDI
- Basic UDI-DI
- 081777002ULTRAMAXO2K8 EUDAMED
- Direct Marketing DI
- 00817770020929 EUDAMED00817770020998 EUDAMED
- 510(k) Number
- FDA Product Code
- CCL FDA 510(k)FDA UDI
- EMDN Code
- Z1203020403 OXYGEN ANALYSERS EUDAMED
- GMDN Term
- Respiratory oxygen monitor, battery-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.1720 FDA 510(k)
- Regulation Number
- 868.1720 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The UltramaxO₂ Oxygen Analyzer is a gaseous-phase gas analyzer designed to measure oxygen concentration in medical and industrial gas mixtures. It operates as a portable device for real-time analysis, ensuring accurate monitoring of oxygen levels in environments where precise gas composition is critical.
This device is supplied as a reusable instrument, intended for use in clinical settings such as operating rooms and anesthesia workstations. It complies with FDA 510(k) clearance under the Abbreviated pathway and is classified as a Class II medical device under regulation number 868.1720. The analyzer requires proper calibration and maintenance to ensure reliable performance, with no specific sterility requirements as it is not intended for direct patient contact.
Frequently asked questions
What clinical environments is the UltramaxO₂ Oxygen Analyzer designed for, and how does its portability benefit users?
The UltramaxO₂ Oxygen Analyzer is specifically designed for clinical settings like operating rooms and anesthesia workstations, where precise monitoring of oxygen levels in gas mixtures is critical. Its portable design allows real-time analysis on-site, ensuring accurate gas composition monitoring without requiring samples to be sent to a centralized lab. This portability enhances workflow efficiency and immediate feedback for patient safety.
Is the UltramaxO₂ Oxygen Analyzer intended for single-use or reusable applications, and what maintenance does it require?
The UltramaxO₂ Oxygen Analyzer is a reusable instrument, not intended for single-use. To maintain reliable performance, it requires proper calibration and regular maintenance as outlined in the manufacturer’s guidelines. Since it does not come with sterility requirements (as it is not for direct patient contact), cleaning and upkeep focus on ensuring sensor accuracy and device longevity.
How is the regulatory pathway for the UltramaxO₂ Oxygen Analyzer structured, and what does the FDA’s classification mean for its use?
The UltramaxO₂ Oxygen Analyzer follows the FDA’s Abbreviated 510(k) pathway, classified as a Class II medical device (regulation number 868.1720) under the Anesthesiology specialty. This classification means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for use in clinical gas monitoring without requiring the rigorous premarket approval process.
Does the UltramaxO₂ Oxygen Analyzer require special storage conditions, and how should it be handled between uses?
The device does not specify unique storage conditions like temperature or humidity constraints in the provided data, but standard environmental controls (e.g., avoiding extreme temperatures or moisture) are recommended for optimal performance. Since it is reusable, it should be stored in a clean, dry location when not in use, following manufacturer instructions for sensor protection and calibration checks to ensure accuracy for subsequent analyses.
What types of gas mixtures can the UltramaxO₂ Oxygen Analyzer measure, and why is real-time analysis important in anesthesia settings?
The UltramaxO₂ Oxygen Analyzer is designed to measure oxygen concentration in medical and industrial gas mixtures, which is essential for verifying the integrity of anesthesia gas blends, ventilator circuits, or oxygen-enriched environments. Real-time analysis is critical in anesthesia to prevent hypoxia, ensure patient safety during procedures, and confirm the correct delivery of gas mixtures—especially in high-risk scenarios like airway management or critical care.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K112402 | Class II | Active |
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Manufacturer
- Manufacturer
- Maxtec, Llc
Sources (5)
- FDA 510(k) K112402 24 fields · synced Sep 18, 2026
- FDA UDI 42f88b1e-82b5-4b57-b961-796f84872cb4 34 fields · synced May 29, 2026
- FDA UDI b0537cec-3cb1-440d-ab4a-0c9793a8dba8 34 fields · synced May 30, 2026
- EUDAMED 5430d3a3-3e50-4f3c-936e-031f997ddc83 61 fields · synced Jul 8, 2026
- EUDAMED 8c8a5fa7-202b-4a13-9c35-ee537a83c293 61 fields · synced Jul 30, 2026