Identity
- Trade Name
- FORE-SIGHT ELITE® FDA UDI
- Generic Name
- Tissue saturation oximeter FDA UDI
- Device Name
- Tissue Oximeter Battery Pack FDA UDI
- Model / Reference
- 01-06-3014 FDA UDI
- Description
- Tissue Oximeter Battery Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10609538630146 FDA UDI
- 510(k) Number
- K143675 FDA UDI
- FDA Product Code
- MUD FDA UDI
- GMDN Term
- Tissue saturation oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tissue saturation oximeter
Fore-Sight Elite® by Cas Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143675 also covers:
- FORE-SIGHT ELITE® — Cas Medical Systems, Inc.
- FORE-SIGHT ELITE® — Cas Medical Systems, Inc.
- FORE-SIGHT ELITE® — Cas Medical Systems, Inc.
- FORE-SIGHT ELITE® — Cas Medical Systems, Inc.
- FORE-SIGHT ELITE® — Cas Medical Systems, Inc.
- FORE-SIGHT ELITE® — Cas Medical Systems, Inc.
- FORE-SIGHT ELITE® — Cas Medical Systems, Inc.
- FORESIGHT ELITE — Edwards Lifesciences LLC
- ForeSight — Edwards Lifesciences LLC
- ForeSight — Edwards Lifesciences LLC
- ForeSight — Edwards Lifesciences LLC
- ForeSight — 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
- Cas Medical Systems, Inc.
Sources (1)
- FDA UDI 1f65bee4-0b2d-48a5-9a32-e6cff44738bb 34 fields · synced Jun 8, 2026