Mada Medical Products, Inc.
A container designed as a refillable cylinder(EMPTY) with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200…
A container designed as a refillable cylinder(EMPTY) with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 – 200 Bar). It is typically NOT filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes. Includes a 1319A carry case.
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 | Mada Medical Products, Inc., United States |
|---|---|
| FDA product code | CAN |
| Device type | Regulator, Pressure, Gas Cylinder |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2700 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-27 |
| Record revised | 2021-03-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R1835-4GB | In distribution | |
| 1309A-5 | In distribution | |
| 1415MS | In distribution | |
| 1359-1 | In distribution | |
| 1358 | In distribution | |
| R1835GBHF-25A | In distribution | |
| 1530E | In distribution | |
| R1833-8G | In distribution | |
| 1630A-15E | In distribution | |
| 1533 | In distribution | |
| M1935-8GB | In distribution | |
| 1308A | In distribution | |
| R1835-15GE | In distribution | |
| 1335-5 | In distribution | |
| 1333 | In distribution | |
| 1443S-15 | In distribution | |
| 1630M-15E | In distribution | |
| 1443-S | In distribution | |
| 1411 | In distribution | |
| R1835-25BR | In distribution | |
| 1443S-5 | In distribution | |
| 1333-1 | In distribution | |
| 1530 | In distribution | |
| 1358-15 | In distribution | |
| R1835-15GB | In distribution | |
| R1836GBHF-25GP | In distribution | |
| R1833-4G | In distribution | |
| 1443-15 | In distribution | |
| 1630 | In distribution | |
| 1335 | In distribution | |
| 1335-1 | In distribution | |
| 1442 | In distribution | |
| 1358-15A | In distribution | |
| 1635-1A | In distribution | |
| R1835-25GBMRI | In distribution | |
| 1531 | In distribution | |
| 1441 | In distribution | |
| R1833GBHF-25 | In distribution | |
| 1529E | In distribution | |
| 1616-AE | In distribution | |
| 1531E | In distribution | |
| 1333-5 | In distribution | |
| 1633-2 | In distribution | |
| 1300BME | In distribution | |
| R1835-25GBHF-25 | In distribution | |
| 1300BM | In distribution | |
| 1635-1 | In distribution | |
| 1309A-15 | In distribution | |
| 1443-5 | In distribution | |
| 1359 | In distribution | |
| 1515A-15 | In distribution | |
| 1633-1A | In distribution | |
| 1616-15E | In distribution | |
| 1630-15 | In distribution | |
| 1633-1 | In distribution | |
| 1301ME | In distribution | |
| 1528B | In distribution | |
| R1835-8GE | In distribution | |
| 1358-1 | In distribution | |
| 1411E | In distribution | |
| 1301M | In distribution | |
| 1442-10 | In distribution | |
| 1528BE | In distribution | |
| 1333-15 | In distribution | |
| 1533E | In distribution | |
| 1309A | In distribution | |
| 1301BME | In distribution | |
| 1335-15 | In distribution | |
| 1309A-1 | In distribution | |
| R1835-25GB | In distribution | |
| 1301BM | In distribution | |
| R1833-15G | In distribution | |
| R1835-8GB | In distribution | |
| R1835-15G | In distribution | |
| 1630-A15 | In distribution | |
| M1935-15GB | In distribution | |
| 1359-15 | In distribution | |
| 1443 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ohio | Ohio Medical LLC | 261 |
| Western/Scott Fetzer | Western Enterprises, Inc. | 178 |
| 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 |
| Gentec® | Gentec (Shanghai) Corporation | 26 |
Showing 12 of 155. All products under Regulator, Pressure, Gas Cylinder
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K950777 | 1995-04-14 |
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.