OxyMask™ O2/EtCO2 Adult Mask With Microstream™ Connector
Catalogue number OM-2125-MDT, listed by Southmedic, Inc., Canada, under Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase. 29 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (17), Jiangsu (5), Zhejiang (3). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Showing 12 of 29. All 29 manufacturers in China registered for Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Record
| Listed by | Southmedic, Inc., Canada |
|---|---|
| FDA product code | CCK |
| Device type | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K014211 |
| Record published | 2018-08-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| OM-2125-MDT | OxyMask™ O2/EtCO2 Adult Mask with Microstream™ connector | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Salter Labs | 241 |
| Microstream | Oridion Medical 1987 Ltd. | 92 |
| Hudson RCI | Teleflex Medical LLC | 79 |
| Medline | Medline Industries, Inc. | 65 |
| BCI | ICU Medical, Inc | 64 |
| Curaplex | Bound Tree Medical, LLC | 60 |
| Microstream Advance | Oridion Medical 1987 Ltd. | 51 |
| Ventlab | Ventlab, LLC | 42 |
| Vital Signs | Carefusion Finland 320 Oy | 33 |
| AirLife™ | Airlife, Inc. | 32 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Nihon Kohden Corp. | 23 |
| Curaplex | TRI-Anim Health Services, Inc. | 23 |
Showing 12 of 441. All products under Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222511 | 2023-11-21 |
| K131410 | 2014-01-13 |
| K014211 | 2002-06-11 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Southmedic, Inc. | 510(k) number | 2017-10-17 | Class II | Device Design | Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. | 8,871 cases (25 masks per case) total | 2024-03-29 |
Recalls
1 of these is Class II. 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 |
|---|---|---|---|---|
| 2021-05-25 | Class II | Nonconforming Material/Component | Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient. | 160 cases (25 units per case) in U.S. |
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.