FDA.report

NA

Primary DI
20763000980096
Brand
NA
Company
MEDTRONIC, INC.
Model
AFR-00015
Device description
IMPEDANCE PATCH AFR-00015
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

Related Records

Product Codes

CodeName
DQKComputer, diagnostic, programmable

Product Code Classifications

CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions

SubmissionSupplement
K241828000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241828000Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.2024-11-01DQK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20763000980096PackageGS14In Commercial Distribution
00763000980092PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods

Method

Contacts

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

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00763000812157NACB9E90R62022-12-31
00763000823580NAHY11W68R32023-01-14
00763000823597NAHY11N74R142023-01-14
00763000823795NAHY12A49R12023-01-15

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