FDA.reportPublic FDA data

Reference Patch CARTO 3

Primary DI
20846835000129
Brand
Reference Patch CARTO 3
Company
Biosense Webster Inc
Model
CREFP6
Catalog number
CREFP6
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20846835000129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084683500012920846835000129

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system reference patchA component of a cardiac mapping system that is an adhesive device placed on the surface of a patient's body, typically the chest and/or back, to provide a fixed reference point for the tip of an internal, non-fluoroscopic catheter during an electrophysiological and electromechanical real-time mapping of the heart. It may be sensor-containing or have a sensor attached to it, and is used to compensate for patient movement during the procedure. It is typically used with a cardiac mapping system computer to assist in the location and navigation of the catheter tip, and to provide electrocardiogram information. This is a single-use 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, Specify00Do not use open or damaged packages
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Keep Dry | Keep out of direct sunlight
Special Storage Condition, Specify00Keep out of direct sunlight
Special Storage Condition, Specify00Store in a cool dry place

Sterilization Methods#

Method table
Method

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10846835026726Dual Energy Thermocool Smarttouch SF CatheterD134711D1347112026-07-09
10846835026733Dual Energy Thermocool Smarttouch SF CatheterD134712D1347122026-07-09
10846835026764Dual Energy Thermocool Smarttouch SF CatheterD134713D1347132026-07-09
10846835026795Dual Energy Thermocool Smarttouch SF CatheterD134811D1348112026-07-09
10846835026825Dual Energy Thermocool Smarttouch SF CatheterD134812D1348122026-07-09
10846835026856Dual Energy Thermocool Smarttouch SF CatheterD134813D1348132026-07-09
10846835026887Dual Energy Thermocool Smarttouch SF CatheterD134814D1348142026-07-09
10846835026917Dual Energy Thermocool Smarttouch SF CatheterD134815D1348152026-07-09
10846835010121Sterile Interface CableD133701D1337012024-12-11
10846835016796TX eco EXT CableD135703D1357032023-10-04
10846835000184N/AC10MR10MSTKSC10MR10MSTKS2017-09-13
10846835000191N/AC5MHDTCMHSC5MHDTCMHS2017-09-13
10846835000207N/AC5MHNAVMHSC5MHNAVMHS2017-09-13
10846835000214N/AC5MHREFMHSC5MHREFMHS2017-09-13
10846835003666N/AC6MR10EPTRSC6MR10EPTRS2017-09-13
10846835003789Carto 3CB3410CTCB3410CT2016-09-16
10846835003796Carto 3CB3412CTCB3412CT2016-09-16
10846835003802Carto 3CB3434CTCB3434CT2016-09-16
10846835003826Carto 3CG2025CTCG2025CT2016-09-16
10846835003857Carto 3CR3425CTCR3425CT2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818087022873MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022880MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022897MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023054MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.DRF2026-05-06
04260192830601EasyMap MAP M (70mm)MedFact Engineering GmbHDRF2026-01-30
04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
04260192832131EasyMap MAP XL (90mm)MedFact Engineering GmbHDRF2026-01-30
24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
00850012226000Axis Patient PatchesCardionxt IncDRF2025-12-10
00850012226154Multilink CS CatheterCardionxt IncDRF2025-12-10
06952450942581EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
06952450942604EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
05414734202701Livewire™ST. JUDE MEDICAL, INC.DRF2023-10-31
00763000445720NAMEDTRONIC, INC.DRF2023-03-18
10801902198379ARROWTELEFLEX INCORPORATEDDRF2022-11-17
10801902198348ARROWTELEFLEX INCORPORATEDDRF2022-10-28
10801902198256ARROWTELEFLEX INCORPORATEDDRF2022-10-21
10801902198317ARROWTELEFLEX INCORPORATEDDRF2022-10-17
10846835018080nGEN GeneratorBiosense Webster IncDRF2022-08-18
10801902211481ARROWTELEFLEX INCORPORATEDDRF2022-06-13
10801902211504ARROWTELEFLEX INCORPORATEDDRF2022-06-13
10801902198300ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198409ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198393ARROWTELEFLEX INCORPORATEDDRF2022-05-11
10801902004533ARROWTELEFLEX INCORPORATEDDRF2018-10-25
20801902004301ARROWTELEFLEX INCORPORATEDDRF2018-10-25
10846835000207N/ABiosense Webster IncDRF2017-09-13