Identity
- Trade Name
- FLOTRAC, VIGILEO FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- CONNECTING CABLE APCO9X2 FDA UDI
- Model / Reference
- APCO9X2 FDA UDI
- Description
- CONNECTING CABLE APCO9X2 FDA UDI
Identifiers
- Catalog Number
- APCO9X2 FDA UDI
- Primary DI / UDI-DI
- 00690103184976 FDA UDI
- 510(k) Number
- K131588 FDA UDI
- FDA Product Code
- DXG FDA UDIDQE FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1435 FDA UDI870.1230 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 216 Inch FDA UDI
Category: Electrical-only medical device connection cable, reusable
Flotrac, Vigileo 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
K131588 also covers:
- FLOTRAC — Edwards Lifesciences LLC
- FLOTRAC — Edwards Lifesciences LLC
- FLOTRAC — Edwards Lifesciences LLC
- FLOTRAC — Edwards Lifesciences LLC
- FLOTRAC — Edwards Lifesciences LLC
- FLOTRAC, TRUWAVE — Edwards Lifesciences LLC
- FLOTRAC, VAMP — Edwards Lifesciences LLC
- FLOTRAC, VAMP — Edwards Lifesciences LLC
- FLOTRAC, VAMP, TRUWAVE — Edwards Lifesciences LLC
- FLOTRAC, VIGILEO — Edwards Lifesciences LLC
- VIGILEO — Edwards Lifesciences LLC
- VIGILEO — 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 c5fe117d-c071-421e-9493-f0d32448a6f0 38 fields · synced Jun 8, 2026