TRUWAVE
- Primary DI
- 57460691958376
- Brand
- TRUWAVE
- Company
- Edwards Lifesciences LLC
- Model
- T531900A
- Catalog number
- T531900A
- Device description
- PRESSURE MONITORING SET
- Published
- 2018-10-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| DXO | Transducer, Pressure, Catheter Tip |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DXO | Transducer, Pressure, Catheter Tip | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 57460691958376 | Package | GS1 | 20 | In Commercial Distribution |
| 07460691958371 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 57460691958376 | 57460691958376 | |
| 07460691958371 | 07460691958371 | 7460691958371 |
GMDN Terms
| Term | Definition |
|---|
| Invasive-pressure external transducer, single-use | A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in a cool, dry place. |
Regulatory Flags
- DUNS number
- 134139174
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 57460691952770 | TRUWAVE | PXMK1077 | PXMK1077 | 2026-03-20 |
| 57460691955887 | TRUWAVE | PXMK1780 | PXMK1780 | 2026-03-20 |
| 00690103000382 | SWAN-GANZ TRUE SIZE | 123F6 | 123F6P | 2026-03-16 |
| 50690103218287 | SWAN-GANZ VIP | 831F75 | 831F75P | 2026-03-16 |
| 50690103218607 | SWAN-GANZ TRUE SIZE | 096F6 | 096F6P | 2026-03-16 |
| 50690103218621 | SWAN-GANZ TRUE SIZE | 111F7 | 111F7P | 2026-03-16 |
| 50690103218638 | SWAN-GANZ TRUE SIZE | 114F7 | 114F7P | 2026-03-16 |
| 00690103221312 | Edwards SAPIEN 3 transcatheter pulmonic valve delivery system | 9631PL20A | 9631PL20A | 2026-02-17 |
| 00690103221329 | Edwards SAPIEN 3 transcatheter pulmonic valve delivery system | 9631PL23A | 9631PL23A | 2026-02-17 |
| 00690103221336 | Edwards SAPIEN 3 transcatheter pulmonic valve delivery system | 9631PL26A | 9631PL26A | 2026-02-17 |
| 00690103221343 | Edwards SAPIEN 3 transcatheter pulmonic valve delivery system | 9631PL29A | 9631PL29A | 2026-02-17 |
| 00690103019353 | AORTIC TRUE-SIZE OBTURATOR 19MM | 1161 | 116119MM | 2026-02-13 |
| 00690103019360 | AORTIC TRUE-SIZE OBTURATOR 21MM | 1161 | 116121MM | 2026-02-13 |
| 00690103019377 | AORTIC TRUE-SIZE OBTURATOR 23MM | 1161 | 116123MM | 2026-02-13 |
| 00690103019384 | AORTIC TRUE-SIZE OBTURATOR 25MM | 1161 | 116125MM | 2026-02-13 |
| 00690103019391 | AORTIC TRUE-SIZE OBTURATOR 27MM | 1161 | 116127MM | 2026-02-13 |
| 00690103019407 | AORTIC TRUE-SIZE OBTURATOR 29MM | 1161 | 116129MM | 2026-02-13 |
| 00690103019414 | AORTIC TRUE-SIZE OBTURATOR 31MM | 1161 | 116131MM | 2026-02-13 |
| 00690103019278 | HEART VALVE SIZER ACCESSORY | 1127 | 112723MM | 2026-02-11 |
| 00690103019285 | HEART VALVE SIZER ACCESSORY | 1127 | 112725MM | 2026-02-11 |
Other Devices Sharing Product Codes