Identity
- Trade Name
- FIRMap FDA UDI
- Generic Name
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
- Device Name
- FIRMap Extension Cable - Global, Non-Sterile FDA UDI
- Model / Reference
- EXC001NS FDA UDI
- Description
- FIRMap Extension Cable - Global, Non-Sterile FDA UDI
Identifiers
- Catalog Number
- EXC001NS FDA UDI
- Primary DI / UDI-DI
- 00810591020079 FDA UDI
- FDA Product Code
- MTD FDA UDI
- GMDN Term
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac mapping catheter, percutaneous, single-use
FIRMap by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac mapping catheter, percutaneous, single-use.
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- Inquiry™ — IRVINE BIOMEDICAL, INC. · Class II
- Woven — Boston Scientific · Class II
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
- Abbott
Sources (1)
- FDA UDI 23d171ad-50d1-4d85-a5d0-4a5c846fd7ed 36 fields · synced Jun 6, 2026