FDA.reportPublic FDA data

Cardiac mapping system reference patch

Definition
A 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.
GUDID devices
40
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00643169006874LOCALISA®MEDTRONIC, INC.96705902016-06-30
00763000871833NAMEDTRONIC, INC.AFR-000072024-10-21
00763000954369N/AMEDTRONIC, INC.AFR-000072025-02-22
00763000980092NAMEDTRONIC, INC.AFR-000152025-08-15
00763000980115NAMEDTRONIC, INC.AFR-000212025-08-15
05415067041715EnSite Precision™ST. JUDE MEDICAL, INC.EN0020-P2022-02-28
05415067056108EnSite™ST. JUDE MEDICAL, INC.ENSITE-RL-MP2026-04-17
07540162100253Globe Positioning System (GPS™) ElectrodesKardium Inc601-000372025-09-15
08714729841890Rhythmia™ Mapping SystemBOSTON SCIENTIFIC CORPORATIONM004RAPATCH102017-03-14
10197106186985CARDINAL HEALTHCardinal Health 200, LLCSAN13CLAJC2023-11-20
10197106317433CARDINAL HEALTHCardinal Health 200, LLCSNE11AN1042023-06-15
10197106521779CARDINAL HEALTHCardinal Health 200, LLCSAN4JATCBA2024-01-29
00850012226000Axis Patient PatchesCardionxt Inc8210102025-12-10
07540162100260Globe Positioning System (GPS™) ElectrodesKardium Inc601-000372025-09-15
20763000980096NAMEDTRONIC, INC.AFR-000152025-08-15
20763000980119NAMEDTRONIC, INC.AFR-000212025-08-15
00850064686111OptiMap™ ECG Cables - NACortex, Inc.FG0012-NA2025-07-24
20763000954363N/AMEDTRONIC, INC.AFR-000072025-02-22
20763000871837NAMEDTRONIC, INC.AFR-000072024-10-21
50197106521777CARDINAL HEALTHCardinal Health 200, LLCSAN4JATCBA2024-01-29
50197106186983CARDINAL HEALTHCardinal Health 200, LLCSAN13CLAJC2023-11-20
50197106317431CARDINAL HEALTHCardinal Health 200, LLCSNE11AN1042023-06-15
15415067041712EnSite Precision™ST. JUDE MEDICAL, INC.EN0020-P2022-02-28
00191506000813Rhythmia HDx™ Mapping SystemBOSTON SCIENTIFIC CORPORATIONM004RAPATCH202022-01-25
00857042007562AcQMapACUTUS MEDICAL, INC.8006052021-10-18
10846835000658RefStar RMT QWIKPATCHBiosense Webster IncRR6PNY2016-09-16
10846835000665RefStar QwikPatchBiosense Webster IncXRP6H2016-09-16
10846835008821RefStar QwikPatchBiosense Webster IncXRPP8Y2017-09-13
05415067032379EnSite™ST. JUDE MEDICAL, INC.ENSITE-SEK-5-012021-01-06
05415067031402EnSite™ST. JUDE MEDICAL, INC.SYS-REF-V12020-07-22
05415067032300EnSite™ST. JUDE MEDICAL, INC.SURF-ELEC-2PRS2020-07-22
05415067032355EnSite Precision™ST. JUDE MEDICAL, INC.PRCN-SEK-A2020-07-22
05414734210003EnSite™ NavX™ST. JUDE MEDICAL, INC.EN0010-1000033312016-05-31
05415067025937EnSite Precision™ST. JUDE MEDICAL, INC.EN0020-P2016-12-20
00857042007210AcQMap®ACUTUS MEDICAL, INC.800365-0032019-07-15
20846835000129Reference Patch CARTO 3Biosense Webster IncCREFP62016-09-16
15414734210000EnSite™ NavX™ST. JUDE MEDICAL, INC.EN0010-1000033312016-05-31
15415067025934EnSite Precision™ST. JUDE MEDICAL, INC.EN0020-P2016-12-20
00857042007036AcQMapACUTUS MEDICAL, INC.800365-0022018-02-15
20643169006878LOCALISA®MEDTRONIC, INC.96705902016-06-30