FDA.reportPublic FDA data

FIRMap

Primary DI
00810591020062
Brand
FIRMap
Company
ABBOTT
Model
US-FOC001NS
Catalog number
US-FOC001NS
Device description
FIRMap Fan Out Cable - US, Non-Sterile
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTDCATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTDCatheter, Intracardiac Mapping, High-Density ArrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810591020062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810591020062008105910200628105910200620810591020062

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping catheter, percutaneous, single-useA sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(650)681-3470aepcustomerservice@abbott.com

Regulatory Flags#

DUNS number
080174723
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810591020154RhythmViewUSB-MEMSTKUSB-MEMSTK2016-09-02
00810591020208RhythmViewRVP4735RVP47352016-09-02
00810591020017FIRMapAR064050AR0640502016-09-02
00810591020024FIRMapAR064060AR0640602016-09-02
00810591020031FIRMapAR064070AR0640702016-09-02
00810591020079FIRMapEXC001NSEXC001NS2016-09-02
00810591020086FIRMapMAC001NSMAC001NS2016-09-02
00810591020109RhythmViewUSB-SSDUSB-SSD2016-09-02
00810591020116RhythmView200020002016-09-02
00810591020130RhythmView200220022016-09-02
30810591020155RhythmViewUSB-MEMSTKUSB-MEMSTK2016-09-02
00810591020161RhythmView2000-R2000-R2016-09-02
00810591020185RhythmView2002-R2002-R2016-09-02
30810591020209RhythmViewRVP4735RVP47352016-09-02
00810591020246FIRMapFOC002NSFOC002NS2016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064686166OptiMap Catheter - 60mmCortex, Inc.MTD2026-05-15
00850064686159OptiMap Catheter - 50mmCortex, Inc.MTD2026-04-02
00850064686067OptiMap™ Catheter - 50mmCortex, Inc.MTD2025-07-24
00850064686074OptiMap™ Catheter - 60mmCortex, Inc.MTD2025-07-10
05415067049889Advisor™ HD Grid X, Sensor Enabled™ST. JUDE MEDICAL, INC.MTD2024-08-23
00841824105560ECOIIW.H.P.M. INC.MTD2024-08-22
00860457001544Ablacon™ Mapping CatheterAblacon Inc.MTD2023-12-07
00860457001551Ablacon™ Mapping CatheterAblacon Inc.MTD2023-12-07
10846835025811OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster IncMTD2023-10-04
10846835025828OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster IncMTD2023-10-04
10846835021110OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021127OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021134OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021141OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021158OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021233OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10888551045179NASTERILMED, INC.MTD2021-10-12
10888551045186NASTERILMED, INC.MTD2021-10-12
10888551045193NASTERILMED, INC.MTD2021-10-12
10888551045209NASTERILMED, INC.MTD2021-10-12
00857042007401AcQMapACUTUS MEDICAL, INC.MTD2021-10-08
00857042007418AcQMapACUTUS MEDICAL, INC.MTD2021-10-08
10846835022056CARTO 3 System eco Interface CableBiosense Webster IncMTD2021-07-30
05415067028198Advisor™ HD Grid, Sensor Enabled™ST. JUDE MEDICAL, INC.MTD2018-05-01
00857042007029AcQMapACUTUS MEDICAL, INC.MTD2018-02-15
08714729780434Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780441Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780458Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780465Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780472Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24