Dispiro
Disposable Spirometer System Kit with 02401, 02020, 02013
10manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
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 | Utah Medical Products, Inc., United States |
|---|---|
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K791177 |
| Record published | 2016-09-22 |
| Record revised | 2019-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Overpack of 4, box of 25 |
| Sizes | Total volume 5 to 10 l; lumen/inner diameter 22 mm; length 14 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5 Liter with Keeper | Total Volume 5 l | 50 | In distribution |
| Kit | Length 14 in | 25 | In distribution |
| Pressure Cap | Length 14 in | 50 | In distribution |
| Mouth Piece | 50 | In distribution | |
| 22mm Connector | Lumen/Inner Diameter 22 mm | 50 | In distribution |
| Custom | In distribution | ||
| 5 Liter with 22 mm Connector | Lumen/Inner Diameter 22 mm | 50 | In distribution |
| 10 Liter with Keeper | Total Volume 10 l | 50 | In distribution |
| 5 Liter Kit | Total Volume 5 l | 25 | In distribution |
| Manifold and Trach Adaptor | 50 | In distribution | |
| Universal Connector | 50 | In distribution | |
| 5 Liter with Connector | Total Volume 5 l | 50 | In distribution |
| 10 Liter Kit | Total Volume 10 l | 25 | In distribution |
| 10 Liter with 22mm Connector | Lumen/Inner Diameter 22 mm | 50 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K791177 | 1979-08-10 |
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.