Identity
- Trade Name
- CO-SET+ FDA UDI
- Generic Name
- Thermal-dilution cardiac output unit FDA UDI
- Device Name
- CO - SET MOD ROOM TEMPERATURE STERILE FDA UDI
- Model / Reference
- MK2431 FDA UDI
- Description
- CO - SET MOD ROOM TEMPERATURE STERILE FDA UDI
Identifiers
- Catalog Number
- MK2431 FDA UDI
- Primary DI / UDI-DI
- 07460691955448 FDA UDI
- 510(k) Number
- K811399 FDA UDI
- FDA Product Code
- KRB FDA UDI
- GMDN Term
- Thermal-dilution cardiac output unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1915 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDI
Category: Thermal-dilution cardiac output unit
Co-Set+ by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Thermal-dilution cardiac output unit.
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- Transonic — Transonic Systems Inc. · Class II
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- CRITIKIT(TM) SP4572 — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- Transonic — Transonic Systems Inc. · Class II
Cleared under the same submission
K811399 also covers:
- CO-SET INJECTATE ICE BUCKET — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — 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 d24bf144-a0af-47d5-9e94-1afcaeda5364 38 fields · synced Jun 8, 2026