Curaplex
Filter,pft,curaplex,mouth Piece,rubber,nose CLIP,26.4MM ID,28.4MM Od,fits Older Jager Models
10manufacturers in China registered for this device type
55catalogue numbers in this listing
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 | TRI-Anim Health Services, Inc., United States |
|---|---|
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K042758 |
| Record published | 2017-02-06 |
| Record revised | 2018-07-06 (version 3) |
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 | serial number |
| Packaging | Pack of 100, pack of 50 |
| Sizes | Lumen/inner diameter 25.4 to 45.5 mm; outer diameter 28.4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 301-PFR9WC | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR6WKN | Lumen/Inner Diameter 45.5 mm | In distribution |
| 301-PFR60WK | Lumen/Inner Diameter 34.5 mm | In distribution |
| 301-PFR8WE2 | Outer Diameter 28.4 mm | In distribution |
| 301-PFR6WKN | Lumen/Inner Diameter 45.5 mm | In distribution |
| 301-PFR70W | Lumen/Inner Diameter 30 mm | In distribution |
| 301-PFR80WE2 | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR80WKN | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR9W | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR80W | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR80WN | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR70W | Lumen/Inner Diameter 30 mm | In distribution |
| 301-PFR80WN | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR8WE2 | Outer Diameter 28.4 mm | In distribution |
| 301-PFR8W | Outer Diameter 28.4 mm | In distribution |
| 301-PFR9WKN | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR6WKN | Lumen/Inner Diameter 45.5 mm | In distribution |
| 301-PFR9W | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR8W | Outer Diameter 28.4 mm | In distribution |
| 301-PFR70WE2N | Lumen/Inner Diameter 30 mm | In distribution |
| 301-PFR60WEL | Lumen/Inner Diameter 34.5 mm | In distribution |
| 301-PFR80WKN | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR9WE2 | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR6WE2 | Lumen/Inner Diameter 45.5 mm | In distribution |
| 301-PFR60W | Lumen/Inner Diameter 34.5 mm | In distribution |
| 301-PFR80WC | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR9WN | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR80WE2 | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR60WE2 | Lumen/Inner Diameter 34.5 mm | In distribution |
| 301-PFR80WC | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR54RMP | In distribution | |
| 301-PFR8W | Outer Diameter 28.4 mm | In distribution |
| 301-PFR70W | Lumen/Inner Diameter 30 mm | In distribution |
| 301-PFR9WC | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR9WNC | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR8WKN | Outer Diameter 28.4 mm | In distribution |
| 301-PFR80WE2 | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR6W | Lumen/Inner Diameter 45.5 mm | In distribution |
| 301-PFR8WKN | Outer Diameter 28.4 mm | In distribution |
| 301-PFR9WN | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR9WE2 | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR8WK | Outer Diameter 28.4 mm | In distribution |
| 301-PFR60WK | Lumen/Inner Diameter 34.5 mm | In distribution |
| 301-PFR80WNC | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR54RMP | In distribution | |
| 301-PFR80WKN | Lumen/Inner Diameter 30.8 mm | In distribution |
| 301-PFR60WK | Lumen/Inner Diameter 34.5 mm | In distribution |
| 301-PFR6WE2 | Lumen/Inner Diameter 45.5 mm | In distribution |
| 301-PFR60WEL | Lumen/Inner Diameter 34.5 mm | In distribution |
| 301-PFR9WNC | Lumen/Inner Diameter 25.4 mm | In distribution |
| 301-PFR60WE2 | Lumen/Inner Diameter 34.5 mm | In distribution |
| 301-PFR54RMP | In distribution | |
| 301-PFR70WN | Lumen/Inner Diameter 30 mm | In distribution |
| 301-PFR70WN | Lumen/Inner Diameter 30 mm | In distribution |
| 301-PFR70WN | Lumen/Inner Diameter 30 mm | 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 |
| 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 |
| Micro Medical | Jaeger Medical GmbH | 25 |
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.