Identity
- Trade Name
- TRUWAVE FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- CABLE ASSEMBLY,EW 6 PIN/LEMO FDA UDI
- Model / Reference
- PX1800 FDA UDI
- Description
- CABLE ASSEMBLY,EW 6 PIN/LEMO FDA UDI
Identifiers
- Catalog Number
- 896050021 FDA UDI
- Primary DI / UDI-DI
- 00690103195880 FDA UDI
- 510(k) Number
- K142749 FDA UDI
- FDA Product Code
- DXO FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 162 Inch FDA UDI
Category: Electrical-only medical device connection cable, reusable
Truwave by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- MICTEC CONNECTION CABLE — SONTEC INSTRUMENTS, INC. · Class II
- ECG Cable — Edan Instruments,Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 30c090ff-4cdb-4cb4-8a88-9869381f5045 38 fields · synced Jun 8, 2026