O-Two
FLOW CONTROL 0-25 LPM O2 DISS. The O-Two Adjustable Oxygen Therapy Flow Controller is a calibrated, 12-position, fixed orifice, non-gravity sensitive flow controller.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Danyang Xinya Valve Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 17 |
| Gentec (Shanghai) Corporation | Shanghai | Shanghai | Manufacturer | 12 |
| Jiangsu Mcare Medical Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 11 |
Record
| Listed by | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | CCN |
| Device type | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2300 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-11-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01FCO125D | In distribution | |
| 01FCO115D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flowmeter Dial | Ohio Medical LLC | 14 |
| Amico Patient Care Corporation | Amico Patient Care Corporation | 6 |
| EM | Allied Medical LLC | 5 |
| Sinya | Danyang Xinya Valve Co., Ltd. | 1 |
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.