MiniOX
Oxygen Analyzer with Sensor
8manufacturers in China registered for this device type
12catalogue 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 | Ohio Medical LLC, United States |
|---|---|
| FDA product code | CCL |
| Device type | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1720 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K961644 |
| Record published | 2016-09-24 |
| Record revised | 2020-04-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2020-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MINIOX 3000 | In distribution | |
| MINIOX 3000S | In distribution | |
| MINIOX 1S | In distribution | |
| MINIOX 1 | In distribution | |
| MINIOX 1A | In distribution | |
| MINIOX 1AS | In distribution | |
| MINIOX 3000 | Withdrawn | |
| MINIOX 1AS | Withdrawn | |
| MINIOX 3000S | Withdrawn | |
| MINIOX 1 | Withdrawn | |
| MINIOX 1A | Withdrawn | |
| MINIOX 1S | Withdrawn |
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 |
| NOxBOXi | Noxbox Limited | 15 |
| Teledyne Analytical Instruments | Teledyne Analytical Instrs | 14 |
| 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
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.