Roberts Oxygen Co., Inc.
Nextgen 3/4-16 Conn Roberts O2
27manufacturers in China registered for this device type
1catalogue number
9recalls on this code
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 | Western Enterprises, Inc., United States |
|---|---|
| FDA product code | CAN |
| Device type | Regulator, Pressure, Gas Cylinder |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2700 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-07 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CROC-9791 | 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
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-01-03 | Class II | Under Investigation by firm | Gauge malfunction: Digital gauge displays an incorrect tank pressure – displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxyge | 24,287 units | |
| 2021-10-16 | Class II | Device Design | VIPR (Valve Integrated Pressure Regulator) – battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke | 40 units | |
| 2021-10-16 | Class II | Device Design | VIPR (Valve Integrated Pressure Regulator) – battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke | 4974 units | |
| 2021-10-16 | Class II | Device Design | VIPR (Valve Integrated Pressure Regulator) – battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke | 40 units | |
| 2015-01-31 | Class I | Component design/selection | The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death. | 162,678 units | 2018-01-18 |
| 2014-04-07 | Class II | Device Design | Separation events have occurred, including the VIPR separating from the Aluminum cylinder. | 118,325 units | 2016-10-14 |
| 2009-08-10 | Not classified | Component design/selection | The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke co | 303 cart assemblies containing 1,212 yoke assemblies (606 Ox | 2012-04-25 |
| 2009-08-10 | Not classified | Component design/selection | The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke co | 42 cart assemblies containing 84 yoke assemblies (42 Oxygen | 2012-04-25 |
| 2009-08-10 | Not classified | Component design/selection | The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke co | 18 cart assemblies containing 72 yoke assemblies (36 Oxygen | 2012-04-25 |
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.