Identity
- Trade Name
- FLOTRAC FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- FLOTRAC SENSOR FDA UDI
- Model / Reference
- MHD65 FDA UDI
- Description
- FLOTRAC SENSOR FDA UDI
Identifiers
- Catalog Number
- MHD65 FDA UDI
- Primary DI / UDI-DI
- 00690103194593 FDA UDI
- FDA Product Code
- DXG FDA UDIDRS FDA UDIDQE FDA UDI
- GMDN Term
- Invasive-pressure external transducer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1435 FDA UDI870.2850 FDA UDI870.1230 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
Category: Invasive-pressure external transducer, single-use
Flotrac 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
K131588 also covers:
- 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
- FLOTRAC, VIGILEO — Edwards Lifesciences LLC
- VIGILEO — Edwards Lifesciences LLC
- VIGILEO — Edwards Lifesciences LLC
K131892 also covers:
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- FLOTRAC — Edwards Lifesciences LLC
K152980 also covers:
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR FOR AFM — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — 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 3ea01aaf-8bae-4916-856a-6022ae8753b6 38 fields · synced Jun 8, 2026