Endophys Pressure Sensing Sheath Kit – 8f 11 CM, No Guidewire
The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer, and a vessel dilator. Used in conjunction with the Endophys…
The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer, and a vessel dilator. Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedures requiring vascular access.
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 | Endophys Holdings, LLC, United States |
|---|---|
| FDA product code | DXO |
| Device type | Transducer, Pressure, Catheter Tip |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2870 |
| Record published | 2024-02-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipper of 5 |
| Sizes | Catheter gauge 8 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSS-10-0811200-SCN-NGW | Catheter Gauge 8 Fr | 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, Vamp Plus | Becton, Dickinson AND Company | 5 |
| 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 |
Showing 12 of 63. All products under Transducer, Pressure, Catheter Tip
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.