FDA.reportPublic FDA data

CARTO 3 System eco Interface Cable

Primary DI
10846835022056
Brand
CARTO 3 System eco Interface Cable
Company
Biosense Webster Inc
Model
D134402
Catalog number
D134402
Device description
Interface Cable
Published
2021-07-30
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193237000Carto Octaray Mapping Catheter with Trueref TechnologyBiosense Webster, Inc.2020-07-31MTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10846835022056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084683502205610846835022056

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Do not use if package is opened
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep out of direct sunlight

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)729-9010RA-BWIUS-Complaints@its.jnj.com

Regulatory Flags#

DUNS number
020163218
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10846835008838SOUNDSTAR10438577104385772016-09-16
10846835009798THERMOCOOL SMARTTOUCH SFD134703D1347032016-11-11
10846835010121Sterile Interface CableD133701D1337012024-12-11
10846835016796TX eco EXT CableD135703D1357032023-10-04
10846835025811OPTRELL Mapping Catheter with TRUEref TechnologyD142902D1429022023-10-04
10846835025828OPTRELL Mapping Catheter with TRUEref TechnologyD142901D1429012023-10-04
10846835017427TX eco CableD140102D1401022023-07-21
10846835016710QDOT MICROD139501D1395012023-07-07
10846835016727QDOT MICROD139502D1395022023-07-07
10846835016734QDOT MICROD139503D1395032023-07-07
10846835016741QDOT MICROD139504D1395042023-07-07
10846835016758QDOT MICROD139505D1395052023-07-07
10846835017045QDOT MICROD139401D1394012023-07-07
10846835017076QDOT MICROD139402D1394022023-07-07
10846835017106QDOT MICROD139403D1394032023-07-07
10846835021110OCTARAY Mapping CatheterD160902D1609022021-10-14
10846835021127OCTARAY Mapping CatheterD160903D1609032021-10-14
10846835021134OCTARAY Mapping CatheterD160906D1609062021-10-14
10846835021141OCTARAY Mapping CatheterD160901D1609012021-10-14
10846835021158OCTARAY Mapping CatheterD160905D1609052021-10-14

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
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
10846835009576PENTARAY NAVBiosense Webster IncMTD2016-09-16