FDA.reportPublic FDA data

FIRMap

Primary DI
00810591020017
Brand
FIRMap
Company
ABBOTT
Model
AR064050
Catalog number
AR064050
Device description
FIRMap Catheter 50mm, PACKAGED - Abbott (Global)
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
00810591020017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810591020017008105910200178105910200170810591020017

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference50Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Atmospheric Pressure50000 KiloPascal106000 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius25 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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810591020154RhythmViewUSB-MEMSTKUSB-MEMSTK2016-09-02
00810591020208RhythmViewRVP4735RVP47352016-09-02
00810591020024FIRMapAR064060AR0640602016-09-02
00810591020031FIRMapAR064070AR0640702016-09-02
00810591020062FIRMapUS-FOC001NSUS-FOC001NS2016-09-02
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