Identity
- Trade Name
- TRUWAVE FDA UDI
- Generic Name
- Pressure transducer dome, single-use FDA UDI
- Device Name
- PRESSURE MONITORING ACCESSORY FDA UDI
- Model / Reference
- 55UF100 FDA UDI
- Description
- PRESSURE MONITORING ACCESSORY FDA UDI
Identifiers
- Catalog Number
- 55UF100 FDA UDI
- Primary DI / UDI-DI
- 07460691952317 FDA UDI
- 510(k) Number
- K142749 FDA UDI
- FDA Product Code
- DXO FDA UDI
- GMDN Term
- Pressure transducer dome, 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
No
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
Category: Pressure transducer dome, single-use
Truwave by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pressure transducer dome, single-use.
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- CRITIFLO(TM) TA1017SM (3ML/HR) — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- Medex — ICU MEDICAL, INC. · Class II
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- Pressure dome - 30034 — Memscap AS · Class II
- SAK1560T — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
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 085ba14f-a00f-46a9-8201-92512723e1c4 38 fields · synced Jun 8, 2026