VBMax
VBMax35, Disposable Pulmonary Function Testing Filter, No Paper Mouthpiece
15manufacturers in China registered for this device type
39catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | A-M Systems, 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) | K000654 |
| Record published | 2016-09-24 |
| Record revised | 2018-08-14 (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, manufacturing date |
| Packaging | Pack of 100, individually bagged of 50, pack of 50, individually bagged of 100, bagged of 10, pack of 10 |
| Sizes | Weight 9 lb |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VBMax30E – 146311 | In distribution | |
| VBMax28S – 136900 | In distribution | |
| VBMax48 – 156800 | In distribution | |
| VBMax35E – 146500 | In distribution | |
| VBMax35S – 136500 | In distribution | |
| VBMax30 – 156300 | Weight 9 lb | In distribution |
| VBMax30 – 156311 | In distribution | |
| VBMax31 – 156700 | In distribution | |
| VBMax34E – 146418 | In distribution | |
| VBMax30E – 146300 | In distribution | |
| VBMax35 – 156500 | Weight 9 lb | In distribution |
| VBMax30 – 156310 | In distribution | |
| VBMax30 – 156304 | In distribution | |
| VBMax35 – 156516 | In distribution | |
| VBMax30S – 136300 | In distribution | |
| VBMax34E – 146400 | In distribution | |
| VBMax36 – 156600 | In distribution | |
| VBMax35E – 146507 | In distribution | |
| VBMax28S – 136907 | In distribution | |
| VBMax30L – 156370 | In distribution | |
| VBMax33 – 156410 | In distribution | |
| VBMax28E – 146907 | In distribution | |
| VBMax36E – 146600 | In distribution | |
| VBMax33 – 156400 | In distribution | |
| VBMax36E – 146607 | In distribution | |
| VBMax31S – 136700 | In distribution | |
| VBMax48 – 156811 | In distribution | |
| VBMax36S – 136607 | In distribution | |
| VBMax28E – 146900 | In distribution | |
| VBMax35 – 156501 | In distribution | |
| VBMax36S – 136600 | In distribution | |
| VBMax35S – 136507 | In distribution | |
| VBMax34S – 136400 | In distribution | |
| VBMax30L – 156301 | In distribution | |
| VBMax35 – 156504 | In distribution | |
| VBMax34S – 136416 | In distribution | |
| VBMax31E – 146700 | In distribution | |
| VBMax35 – 156511 | In distribution | |
| VBMax35 – 156514 | 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 |
| Vital Signs™ | AirLife Finland Oy | 38 |
| McKesson | Mckesson Medical-Surgical Inc. | 31 |
Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130664 | 2013-06-21 |
| K063526 | 2007-06-29 |
| K000654 | 2000-11-14 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-03-31 | Not classified | Nonconforming Material/Component | Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together. | 37800 | 2012-01-05 |
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.