CONTEC Oxygen Concentrator
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Oxygen Concentrator EUDAMEDCONTEC FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Oxygen Concentrator EUDAMEDFDA UDI
- Model / Reference
- CONTEC21 EUDAMEDFDA UDI
- Description
- Oxygen Concentrator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040105565 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450401CONTEC21WV EUDAMED
- Direct Marketing DI
- 06945040105565 EUDAMED
- 510(k) Number
- FDA Product Code
- CAW FDA 510(k)FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)FDA UDI
- Market of Registration
- Poland 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
Yes
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Contec Oxygen Concentrator OC5B is a portable medical-grade oxygen generator classified as a Generator, Oxygen, Portable. It employs pressure swing adsorption (PSA) technology with a molecular sieve to concentrate oxygen from ambient air, delivering high-concentration medical oxygen for therapeutic use. Designed for clinical and home settings, it provides a reliable source of oxygen without the need for liquid or compressed gas cylinders.
Supplied as a reusable device, the OC5B is intended for use in controlled environments such as hospitals, clinics, or patient homes. It operates with a 5-liter flow rate and requires no sterilisation, though proper maintenance of its adsorption towers and components is essential for performance. The device complies with FDA 510(k) clearance and MDR regulations, with a classification under OpenFDA device code CAW. No MRI safety or single-use specifications are indicated.
Frequently asked questions
How does the Contec Oxygen Concentrator OC5B differ from traditional oxygen tanks in terms of operation and convenience?
The Contec Oxygen Concentrator OC5B generates medical-grade oxygen on-demand from ambient air using pressure swing adsorption (PSA) technology, eliminating the need for liquid or compressed gas cylinders. This makes it highly portable and convenient for both clinical and home use, as it doesn’t require refilling or replenishing oxygen sources. It delivers a continuous flow rate of 5 liters per minute, providing a reliable oxygen supply without the logistical challenges of managing tanks.
Is the OC5B designed for single-use or repeated use, and what maintenance is required to ensure proper function?
The OC5B is a reusable device intended for long-term use in controlled environments like hospitals, clinics, or patient homes. While it doesn’t require sterilization, regular maintenance of its adsorption towers and components is critical to sustain performance. The manufacturer emphasizes proper upkeep to ensure consistent oxygen generation, as the device relies on molecular sieve technology that may degrade over time with improper care.
What regulatory pathways has the Contec Oxygen Concentrator OC5B followed, and how does this affect its use in clinical settings?
The OC5B has obtained FDA 510(k) clearance and complies with the EU’s Medical Device Regulation (MDR), demonstrating its adherence to stringent safety and performance standards. These approvals confirm its classification as a portable oxygen generator and validate its suitability for therapeutic use in both clinical and homecare settings. The device’s regulatory route ensures it meets established guidelines for medical-grade oxygen delivery.
Can the OC5B be used in environments where MRI compatibility is a concern, and if not, what alternatives should be considered?
The provided data does not specify MRI safety for the OC5B, meaning its compatibility with MRI environments is not confirmed. If used near MRI machines, caution is advised, as the device’s electronic components or metal parts could pose risks. Clinicians should consult the manufacturer’s guidelines or opt for MRI-safe alternatives if proximity to MRI equipment is unavoidable.
What flow rate does the OC5B provide, and how does this compare to other portable oxygen devices?
The OC5B delivers a fixed flow rate of 5 liters per minute, which is standard for many portable oxygen concentrators designed for therapeutic use. This output is sufficient for patients requiring moderate oxygen supplementation, though higher flow rates may be necessary for more severe cases. The device’s consistent delivery makes it suitable for both clinical and home settings where a reliable, cylinder-free oxygen source is needed.
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. Sources consulted: OC5B Oxygen Concentrator-CONTEC MEDICAL SYSTEMS CO.,LTD, Oxygen Concentrator-CONTEC Medical Systems Co., Ltd, CONTEC21 Oxygen Concentrator-CONTEC MEDICAL SYSTEMS CO.,LTD, CONTEC hospital professional oxygen generator 10L oxygen concentrator ...
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 | K180837 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical System Co., Ltd.
Sources (3)
- FDA 510(k) K180837 24 fields · synced Sep 18, 2026
- FDA UDI df4a9b64-7e17-4fbd-bebb-aeb4ee6705fa 34 fields · synced May 30, 2026
- EUDAMED 8274b22b-7174-4862-be26-d54714561928 61 fields · synced Jul 16, 2026