NOxBOXi
Single use tubing for connection between NOxMixer and NOxFLOW during back up mode
8manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
Record
| Listed by | Noxbox Limited, United Kingdom |
|---|---|
| FDA product code | CCL |
| Device type | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1720 |
| Establishment | Manufacturer |
| 510(k) | K171696 |
| Record published | 2018-11-05 |
| Record revised | 2019-01-10 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature 0 to 40 °C; Storage environment humidity 15 to 95 % RH; Storage environment atmospheric pressure 800 to 1200 millibar; Handling environment temperature 10 to 40 °C; Handling environment humidity 15 to 85 % RH; Handling environment atmospheric pressure 800 to 1200 millibar |
| Packaging | Box of 999999999, carton of 4, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NOXDC-I | In distribution | ||
| CON158 | 25 | In distribution | |
| FXS555 | 25 | In distribution | |
| NOXKIT-1-10 | In distribution | ||
| NOXKIT-2-22 | In distribution | ||
| NOXKIT-EMER | 10 | In distribution | |
| NOXBOX-I | In distribution | ||
| 034-18-00520-V | In distribution | ||
| NOXKIT-2-12 | In distribution | ||
| 034-20-01010-V | In distribution | ||
| FIL063 | 100 | In distribution | |
| NOXBOX-I TEST | In distribution | ||
| NOXKIT-2-15 | In distribution | ||
| FIL064 | 50 | In distribution | |
| NOXKIT-HFJV | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O2-Sensor | IT DR. Gambert Gmbh | 90 |
| Analytical Industries Inc. | Analytical Industries, Inc. | 70 |
| Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 40 |
| Vital Signs™ | AirLife Finland Oy | 27 |
| MaxVenturi | Maxtec, LLC | 24 |
| Sensoronics | Sensoronics Incorporated | 15 |
| Teledyne Analytical Instruments | Teledyne Analytical Instrs | 14 |
| MiniOX | Ohio Medical LLC | 12 |
| Vital Signs | Carefusion Finland 320 Oy | 10 |
| Oxygen Sensor | Maxtec, LLC | 8 |
| MAX-250 | Maxtec, LLC | 7 |
| Bird SENTRY2 | Carefusion | 5 |
Showing 12 of 165. All products under Analyzer, Gas, Oxygen, Gaseous-Phase
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Noxbox Limited | 510(k) number | 2026-08-19 | Not classified | Device Design | Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation. | 1,547 units | |
| Noxbox Limited | 510(k) number | 2025-09-09 | Class I | Software design | Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunne | 1667 units | |
| Noxbox Limited | 510(k) number | 2025-09-09 | Class I | Software design | The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts. | 1667 units | |
| Noxbox Limited | 510(k) number | 2023-07-19 | Class II | Component design/selection | Replacement of the internal Sample Pump due to high failure rates. | 1,667 units | |
| Noxbox Limited | 510(k) number | 2023-05-03 | Class I | Component change control | Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a wors | 548 (US); 208 (OUS) | 2024-10-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.