TruWave, Vamp Plus
5 catalogue numbers from PXVP2284, listed by Becton, Dickinson AND Company, United States, under Transducer, Pressure, Catheter Tip. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | DXO |
| Device type | Transducer, Pressure, Catheter Tip |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2870 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K183413 |
| Record published | 2026-05-30 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place; Special storage condition: Keep away from sunlight; Special storage condition: Keep dry |
| Packaging | Case of 10 |
| Sizes | Length 72 to 84 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PXVP2284 | Length 84 in | In distribution |
| PXVP2272 | Total Volume = 3 cubic centimetre (cu cm or cm3) | In distribution |
| PXVP2284AT3 | Total Volume = 3 cubic centimetre (cu cm or cm3) | In distribution |
| PXVP0566 | Length 82 in | In distribution |
| PXVP23X3AT3 | Total Volume = 3 cubic centimetre (cu cm or cm3) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Truwave | Edwards Lifesciences Technology Sarl | 456 |
| OptoMonitor 3 | Opsens Inc. | 73 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 45 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 24 |
| PX1800 → Truwave Cables | Edwards Lifesciences Technology Sarl | 22 |
| Truwave, Vamp JR | Edwards Lifesciences Technology Sarl | 12 |
| Truwave Cables | Edwards Lifesciences Technology Sarl | 7 |
| TruWave | Becton, Dickinson AND Company | 4 |
| Comet | Boston Scientific Corporation | 4 |
| Medline Industries, Inc. | Medline Industries, Inc. | 4 |
| Pressure Tubing | Edwards Lifesciences Technology Sarl | 3 |
| OptoMonitor | Opsens Inc. | 3 |
Showing 12 of 63. All products under Transducer, Pressure, Catheter Tip
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | UDI-DI | 2023-10-04 | Class II | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | 168,014 units |
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.