Identity
- Trade Name
- HeartLight FDA UDI
- Generic Name
- Flexible fibreoptic arterioscope, reusable FDA UDI
- Device Name
- Endoscope FDA UDI
- Model / Reference
- 18-1447 FDA UDI
- Description
- Endoscope FDA UDI
Identifiers
- Catalog Number
- 18-1447 FDA UDI
- Primary DI / UDI-DI
- 00868976000123 FDA UDI
- PMA Number
- P150026 FDA UDI
- FDA Product Code
- OAE FDA UDI
- GMDN Term
- Flexible fibreoptic arterioscope, reusable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Flexible fibreoptic arterioscope, reusable
HeartLight by Cardiofocus, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P150026 also covers:
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
- HeartLight — Cardiofocus, Inc.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Cardiofocus, Inc.
Sources (1)
- FDA UDI c2ffcece-aa89-407a-9933-a436c86c9bfa 36 fields · synced May 31, 2026