Identity
- Trade Name
- TruWave FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- Pressure Monitoring Set FDA UDI
- Model / Reference
- PXVPZ10025 FDA UDI
- Description
- Pressure Monitoring Set FDA UDI
Identifiers
- Catalog Number
- PXVPZ10025 FDA UDI
- Primary DI / UDI-DI
- 00690103216806 FDA UDI
- 510(k) Number
- K142749 FDA UDI
- FDA Product Code
- DXO FDA UDI
- GMDN Term
- Invasive-pressure external transducer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Invasive-pressure external transducer, single-use
TruWave by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142749 also covers:
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
- TRUWAVE — Edwards Lifesciences LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 511867b0-7a6f-496a-b13a-99cbcfe03459 38 fields · synced Jun 8, 2026