Pneuton
Bacterial/Viral Filter, main line or expiratory
15manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (4), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
Showing 12 of 15. All 15 manufacturers in China registered for Filter, Bacterial, Breathing-Circuit
Record
| Listed by | Airon Corporation, United States |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K925217 |
| Record published | 2017-01-10 |
| Record revised | 2020-02-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment humidity 15 to 95 % RH; Handling environment temperature 23 to 104 °F; Storage environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F |
| Packaging | Pack of 50 |
| Sizes | Weight 0.04 lb; height 2.5 in; width 2.5 in; length 2.75 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 58210 | Weight 0.04 lb | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 405 |
| Pulmoguard | S D I Diagnostics Inc | 203 |
| Cardinal Health | Cardinal Health 200, LLC | 131 |
| DAR | Covidien LP | 110 |
| Portex | ICU Medical, Inc | 108 |
| Vital Signs™ | SunMed Group Holdings, LLC | 78 |
| Pentair | Pentair Filtration Solutions | 68 |
| Disposable Anesthesia Circuits | Westmed, Inc. | 68 |
| AirLife™ | AirLife Finland Oy | 43 |
| Ventlab | Ventlab, LLC | 40 |
| VBMax | A-M Systems | 39 |
| Vital Signs™ | AirLife Finland Oy | 38 |
Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | 510(k) number | 2025-10-10 | Class I | Nonconforming Material/Component | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120″ expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may resu | 96,406 total units |
| Medline Industries, LP – Northfield | 510(k) number | 2024-04-08 | Class II | Under Investigation by firm | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
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.