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Primary ID: P040014
THERAPY CARDIAC ABLATION SYSTEM (UDI P040014)
Manufactured by Irvine Biomedical, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for THERAPY CARDIAC ABLATION SYSTEM - Primary ID P040014
Device Regulatory Overview
The THERAPY CARDIAC ABLATION SYSTEM (Model/Catalog Number: Unspecified) is a medical device manufactured by Irvine Biomedical, Inc.. This product is indexed under FDA Product Code / Category Classification LPB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- LPB
- Device Name
- Cardiac ablation percutaneous catheter
- Database Sync Date
- 2026-08-09 10:05:00
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of THERAPY CARDIAC ABLATION SYSTEM?
The registered manufacturer of record for THERAPY CARDIAC ABLATION SYSTEM is Irvine Biomedical, Inc..
What is the Primary UDI-DI identifier for THERAPY CARDIAC ABLATION SYSTEM?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P040014.
What classification code is assigned to this device?
This device is registered under product classification code LPB.
Similar Classification Devices (LPB)
Other Devices by Irvine Biomedical, Inc.
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