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FIRMap

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
FIRMap FDA UDI
Generic Name
Cardiac mapping catheter, percutaneous, single-use FDA UDI
Device Name
FIRMap Catheter Fan Out Cable (2m) - Abbott (Global), Non-Sterile FDA UDI
Model / Reference
FOC002NS FDA UDI
Description
FIRMap Catheter Fan Out Cable (2m) - Abbott (Global), Non-Sterile FDA UDI

Identifiers

Catalog Number
FOC002NS FDA UDI
Primary DI / UDI-DI
00810591020246 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

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

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

Similar devices

Also classified as Cardiac mapping catheter, percutaneous, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI a8158417-c842-40bc-b958-fe4cdea71382 36 fields · synced Jun 8, 2026