FDA.reportPublic FDA data

NA

Primary DI
20763000980119
Brand
NA
Company
MEDTRONIC, INC.
Model
AFR-00021
Device description
MAGNETIC PATCH AFR-00021
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQKComputer, diagnostic, programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243435000Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.2024-12-05DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000980119PackageGS14In Commercial Distribution
00763000980115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300098011920763000980119
00763000980115007630009801157630009801150763000980115

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, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
B353UA2251DA1UbiqVueLifesignals, Inc.DQK2025-04-22
B353UA2251SA1UbiqVueLifesignals, Inc.DQK2025-04-22
00195278364661CardioSoftGE Medical Systems Information Technologies, Inc.DQK2025-03-25
00843152101078IOPS ViewpointCenterline Biomedical, Inc.DQK2024-10-01
00843152101108IOPS ViewpointCenterline Biomedical, Inc.DQK2024-10-01
00843152101115IOPS ViewpointCenterline Biomedical, Inc.DQK2024-10-01
00843152101061IOPS ViewpointCenterline Biomedical, Inc.DQK2024-10-01
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23