FDA.reportPublic FDA data

Axis Patient Patches

Primary DI
00850012226000
Brand
Axis Patient Patches
Company
Cardionxt Inc
Model
821010
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201094000iMap 3D Mapping & Navigation System (iMap System)Cardionxt, Inc.2021-08-16DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850012226007PackageGS110In Commercial Distribution
00850012226000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001222600710850012226007
00850012226000008500122260008500122260000850012226000

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117364041
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012226338iMap Software8205012026-04-09
00850012226406iMap Computer Cart8255002026-04-09
00850012226291iMap 3D Mapping and Navigation System8200002025-12-10
00850012226154Multilink CS Catheter8210032025-12-10

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
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
00643169778184NAMEDTRONIC, INC.DRF2016-11-04
08714729082002SteeroCath-Dx™BOSTON SCIENTIFIC CORPORATIONDRF2016-09-24