CO2
The CO2 Regulator System is intended to supply low pressure CO2, where small volumes of CO2 are needed, during medical procedures. The device is not intended to be marketed for any specific…
The CO2 Regulator System is intended to supply low pressure CO2, where small volumes of CO2 are needed, during medical procedures. The device is not intended to be marketed for any specific treatment or medical purpose.The CO2 Cartridge is a component of the Avinger CO2 Regulator System which also includes a CO2 regulator (regulator), male luer lock connector and a female-female luer lock connector (removable). The Avinger CO2 Regulator System allows for the CO2 cartridge to be replaced once the gas from the engaged CO2 cartridge has been spent. Replacement CO2 Cartridges are shipped in packs of five (5).
Who Else Makes It
Concentrated in Jiangsu (14), Guangdong (4), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Cofoe Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 22 |
| Jiangsu Yuyue Medical Equipment & Supply Company Limited | Jiangsu | Jiangsu | Contract manufacturer | 17 |
| Foshan City Nanhai Chiahui Hardware&Plastic Product Co Ltd | Danzao, Foshan | Guangdong | Contract manufacturer | 1 |
| Ninghai Dingli Water-Heating Equipment Plant | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| A & I Industries Ltd | Foshan | Guangdong | Manufacturer | 35 |
| Emsrun Group | Wuxi | Jiangsu | Specification developer | 34 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
Showing 12 of 27. All 27 manufacturers in China registered for Regulator, Pressure, Gas Cylinder
Record
| Listed by | Avinger, Inc., United States |
|---|---|
| FDA product code | CAN |
| Device type | Regulator, Pressure, Gas Cylinder |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2700 |
| Premarket notification | Exempt |
| Record published | 2019-03-21 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ohio | Ohio Medical LLC | 261 |
| Western/Scott Fetzer | Western Enterprises, Inc. | 178 |
| Mada Medical Products, Inc. | Mada Medical Products, Inc. | 78 |
| Sinya | Danyang Xinya Valve Co., Ltd. | 47 |
| Control Devices | Control Devices, LLC | 41 |
| Regulator, Pressure, Gas Cylinder | Control Devices, LLC | 38 |
| The Harris Products Group | J. W. Harris Co., Inc. | 37 |
| PC | Allied Medical LLC | 35 |
| BF | Allied Medical LLC | 34 |
| MediSelect II | GCE, s.r.o. | 28 |
| Varimed+ | GCE, s.r.o. | 28 |
| EM | Allied Medical LLC | 27 |
Showing 12 of 155. All products under Regulator, Pressure, Gas Cylinder
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.