Pulmoguard
Bacterial Filter, noseclip and mouthpiece
15manufacturers in China registered for this device type
203catalogue numbers in this listing
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 | S D I Diagnostics Inc |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| 510(k) | K934509 |
| Record published | 2016-07-25 |
| Record revised | 2022-06-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Packaging | Case of 50, case of 4, pack of 200, case of 25 |
| Distribution end date | 2023-10-17 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| II | 300 | In distribution | |
| V | 50 | In distribution | |
| C | 100 | In distribution | |
| IQ | 25 | In distribution | |
| II, Klip | 100 | In distribution | |
| I | 100 | In distribution | |
| I | 200 | In distribution | |
| N | 50 | In distribution | |
| S | 80 | In distribution | |
| MG | 300 | In distribution | |
| IQ | 100 | In distribution | |
| S, Comfit Mouthpiece, Kushion Klip | 80 | In distribution | |
| II Comfit Mouthpiece & Kushion KlipKlip | 40 | In distribution | |
| II, Kushion Klip | 100 | In distribution | |
| A | 50 | In distribution | |
| II | 50 | In distribution | |
| II | 50 | In distribution | |
| S | 100 | In distribution | |
| N | 50 | In distribution | |
| I | 50 | In distribution | |
| II | 40 | In distribution | |
| A | 50 | In distribution | |
| Cardboard Mouthpiece | 100 | In distribution | |
| MG, Kushion Klip | 50 | In distribution | |
| A | 50 | In distribution | |
| II Comfit Mouthpiece & Kushion KlipKlip | 80 | In distribution | |
| I | 50 | In distribution | |
| I | 80 | In distribution | |
| N | 200 | In distribution | |
| C, Comfit Mouthpiece | 100 | In distribution | |
| Comfit Mouthpiece & Klip | 40 | In distribution | |
| II, Kushion Klip, Flotube | 100 | In distribution | |
| I | 40 | In distribution | |
| I | 40 | In distribution | |
| II | 100 | In distribution | |
| Cardboard Mouthpiece | 50 | In distribution | |
| C, Comfit Mouthpiece, Kushion Klip | 50 | In distribution | |
| II | 100 | In distribution | |
| Cardboard Mouthpiece & Kushion Klip | 80 | In distribution | |
| S | 50 | In distribution | |
| Comfit Mouthpiece | 80 | In distribution | |
| Kushion Klip | 100 | In distribution | |
| II | 40 | In distribution | |
| V | 80 | In distribution | |
| S, Comfit Mouthpiece | 80 | In distribution | |
| MG | 50 | In distribution | |
| IQ | 100 | In distribution | |
| Comfit Mouthpiece & Kushion Klip | 80 | In distribution | |
| Pulmoguard | 50 | In distribution | |
| I | 80 | In distribution | |
| Comfit Mouthpiece & Kushion Klip | 40 | In distribution | |
| I | 50 | In distribution | |
| II | 200 | In distribution | |
| I | 100 | In distribution | |
| A | 50 | In distribution | |
| II | 50 | In distribution | |
| S, Comfit Mouthpiece, Kushion Klip | 40 | In distribution | |
| IQ, Kushion Klip | 25 | In distribution | |
| Comfit Mouthpiece & Klip | 80 | In distribution | |
| V | 300 | In distribution | |
| IQ, Kushion Klip | 300 | In distribution | |
| I | 50 | In distribution | |
| MG | 100 | In distribution | |
| S | 100 | In distribution | |
| I | 300 | In distribution | |
| C | 50 | In distribution | |
| C | 100 | In distribution | |
| C | 100 | In distribution | |
| I | 40 | In distribution | |
| C | 50 | In distribution | |
| II | 300 | In distribution | |
| IQ | 300 | In distribution | |
| C, Kushion Klip | 100 | In distribution | |
| II, Kushion Klip | 50 | In distribution | |
| S, Kushion Klip | 100 | In distribution | |
| II Cardboard Mouthpiece, Klip | 80 | In distribution | |
| II | 80 | In distribution | |
| I | 80 | In distribution | |
| II | 300 | In distribution | |
| C, Comfit Mouthpiece, Kushion Klip | 100 | In distribution | |
| MG | 50 | In distribution | |
| S, Kushion Klip | 50 | In distribution | |
| MG, Comfit Mouthpiece, Kushion Klip | 50 | In distribution | |
| C | 100 | In distribution | |
| S | 50 | In distribution | |
| Cardboard Mouthpiece & Klip | 80 | In distribution | |
| Klip | 100 | In distribution | |
| V | 50 | In distribution | |
| I | 40 | In distribution | |
| C | 50 | In distribution | |
| I | 100 | In distribution | |
| II | 200 | In distribution | |
| C | 100 | In distribution | |
| Pulmoguard | 300 | In distribution | |
| Comfit Mouthpiece | 40 | In distribution | |
| IQ | 300 | In distribution | |
| II | 80 | In distribution | |
| II | 50 | In distribution | |
| IQ | 300 | In distribution | |
| S | 300 | In distribution | |
| S | 200 | In distribution | |
| Cardboard Mouthpiece & Kushion Klip | 40 | In distribution | |
| I | 80 | In distribution | |
| Pulmoguard | 100 | In distribution | |
| IQ | 25 | In distribution | |
| II | 100 | Withdrawn | |
| I | 80 | Withdrawn | |
| IQ | 25 | Withdrawn | |
| MG | 50 | Withdrawn | |
| II Cardboard Mouthpiece, Klip | 80 | Withdrawn | |
| II | 80 | Withdrawn | |
| II | 100 | Withdrawn | |
| II | 80 | Withdrawn | |
| I | 100 | Withdrawn | |
| II | 50 | Withdrawn | |
| II | 300 | Withdrawn | |
| II Comfit Mouthpiece & Kushion Klip & Adapter | 80 | Withdrawn | |
| II | 80 | Withdrawn | |
| S | 300 | Withdrawn | |
| Klip | 50 | Withdrawn | |
| II | 50 | Withdrawn | |
| IQ | 25 | Withdrawn | |
| II | 50 | Withdrawn | |
| II, Klip | 50 | Withdrawn | |
| S | 40 | Withdrawn | |
| S, Comfit Mouthpiece | 40 | Withdrawn | |
| II, Kushion Klip, Flotube | 50 | Withdrawn | |
| S | 50 | Withdrawn | |
| II Cardboard Mouthpiece | 100 | Withdrawn | |
| S | 100 | Withdrawn | |
| II | 50 | Withdrawn | |
| IQ Guard | 25 | Withdrawn | |
| MG | 50 | Withdrawn | |
| II | 300 | Withdrawn | |
| II Comfit Mouthpiece & Kushion Klip & Adapter | 40 | Withdrawn | |
| II | 40 | Withdrawn | |
| C | 50 | Withdrawn | |
| II | 100 | Withdrawn | |
| II Cardboard Mouthpiece, Kushion Klip | 80 | Withdrawn | |
| II | 25 | Withdrawn | |
| II | 100 | Withdrawn | |
| C | 50 | Withdrawn | |
| II | 25 | Withdrawn | |
| II | 50 | Withdrawn | |
| IQ Guard | 300 | Withdrawn | |
| IQ Guard | 25 | Withdrawn | |
| II Comfit Mouthpiece & Klip | 40 | Withdrawn | |
| C, Kushion Klip | 50 | Withdrawn | |
| II Cardboard Mouthpiece, Kushion Klip | 40 | Withdrawn | |
| II | 40 | Withdrawn | |
| II, Flotube | 50 | Withdrawn | |
| C | 50 | Withdrawn | |
| IQ | 300 | Withdrawn | |
| Kushion Klip | 50 | Withdrawn | |
| IQ | 300 | Withdrawn | |
| II Comfit Mouthpiece, Adapter | 80 | Withdrawn | |
| IQ Guard | 300 | Withdrawn | |
| IQ | 25 | Withdrawn | |
| II | 40 | Withdrawn | |
| II Cardboard Mouthpiece, Klip | 40 | Withdrawn | |
| II Cardboard Mouthpiece | 50 | Withdrawn | |
| II Comfit Mouthpiece | 40 | Withdrawn | |
| S | 40 | Withdrawn | |
| MG, Comfit Mouthpiece | 50 | Withdrawn | |
| II | 40 | Withdrawn | |
| I | 40 | Withdrawn | |
| C, Comfit Mouthpiece | 50 | Withdrawn | |
| II | 100 | Withdrawn | |
| II | 40 | Withdrawn | |
| II, Flotube | 100 | Withdrawn | |
| II | 80 | Withdrawn | |
| II | 80 | Withdrawn | |
| II | 100 | Withdrawn | |
| N, Kushion Klip | 50 | Withdrawn | |
| II Cardboard Mouthpiece, Kushion Klip | 40 | Withdrawn | |
| II Comfit Mouthpiece | 80 | Withdrawn | |
| N | 50 | Withdrawn | |
| II | 80 | Withdrawn | |
| II Cardboard Mouthpiece, Kushion Klip | 80 | Withdrawn | |
| S | 80 | Withdrawn | |
| II Comfit Mouthpiece & Klip | 80 | Withdrawn | |
| II Cardboard Mouthpiece | 50 | Withdrawn | |
| II Comfit Mouthpiece, Adapter | 40 | Withdrawn | |
| II Cardboard Mouthpiece, Klip | 40 | Withdrawn | |
| C | 100 | Withdrawn | |
| II | 100 | Withdrawn | |
| C | 50 | Withdrawn | |
| C | 100 | Withdrawn | |
| II | 40 | Withdrawn | |
| II | 100 | Withdrawn | |
| II | 50 | Withdrawn | |
| II Cardboard Mouthpiece | 100 | Withdrawn | |
| II | 50 | Withdrawn | |
| II | 40 | Withdrawn | |
| Cardboard Mouthpiece & Klip | 40 | Withdrawn | |
| C | 100 | Withdrawn | |
| II, Kushion Klip | 25 | Withdrawn | |
| II | 100 | Withdrawn | |
| II Kushion Klip, Adapter | 100 | Withdrawn | |
| II | 80 | Withdrawn | |
| MG | 100 | Withdrawn | |
| S, Comfit Mouthpiece, Klip | 80 | Withdrawn | |
| II Kushion Klip, Adapter | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 405 |
| 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 31 |
Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit
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.