Spiroguard
Catalogue number 2800/21BAUC001/0001, listed by GVS Filter Technology UK Ltd, United Kingdom, under Spirometer, Diagnostic. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Fujian (1). 7 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 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Flexible Circuit Technologies Shenzhen | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Feellife Health Inc. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | GVS Filter Technology UK Ltd, United Kingdom |
|---|---|
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K051712 |
| Record published | 2016-09-23 |
| Record revised | 2026-02-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -5 to 40 °C |
| Packaging | Outer box of 200, inner box of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2800/21BAUC001/0001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Polytech Filter | Polytechnic Resources, Inc. | 190 |
| Model 4000 | Vitalograph Ireland Ltd. | 115 |
| Astra Spirometer | S D I Diagnostics Inc | 90 |
| MIR | Mir Medical International Research | 56 |
| Curaplex | TRI-Anim Health Services, Inc. | 55 |
| Alpha | Vitalograph Ireland Ltd. | 48 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 47 |
| MGC Diagnostics | Medical Graphics Corp. | 42 |
| Astraguard | S D I Diagnostics Inc | 39 |
| PFT | Vitalograph Ireland Ltd. | 38 |
| Vyaire | Jaeger Medical GmbH | 36 |
| BVF | Vitalograph Ireland Ltd. | 29 |
Showing 12 of 123. All products under Spirometer, Diagnostic
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.