FDA.reportPublic FDA data

Globe Positioning System (GPS™) Electrodes

Primary DI
07540162100253
Brand
Globe Positioning System (GPS™) Electrodes
Company
Kardium Inc
Model
601-00037
Published
2025-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

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
K250747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250747000Globe® Pulsed Field SystemKardium, Inc.2025-06-25DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540162100260PackageGS14In Commercial Distribution
07540162100253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540162100260075401621002607540162100260
07540162100253075401621002537540162100253

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.

Regulatory Flags#

DUNS number
248480043
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
07540162100185Globe® Introducer601-010012025-09-15
07540162100239Globe Positioning System (GPS™) Cable601-000362025-09-15
07540162100277Globe® Catheter Cable601-000462025-09-15
07540162100291Globe® Controller601-000482025-09-15
07540162100307Globe® Workstation601-000642025-09-15
07540162100321Globe® PF Generator601-000602025-09-15
07540162100338Globe® Platform601-000662025-09-15
07540162100352Globe® Catheter Cable Support601-000672025-09-15
07540162100154Globe® Catheter601-010002025-09-15
07540162100192Globe® Introducer601-010012025-09-15
07540162100246Globe Positioning System (GPS™) Cable601-000362025-09-15
07540162100260Globe Positioning System (GPS™) Electrodes601-000372025-09-15
07540162100284Globe® Catheter Cable601-000462025-09-15
07540162100215Globe® Controller601-000482025-09-15
07540162100314Globe® Workstation601-000642025-09-15
07540162100222Globe® PF Generator601-000602025-09-15
07540162100345Globe® Platform601-000662025-09-15
07540162100369Globe® Catheter Cable Support601-000672025-09-15

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Primary DI, Brand, Company table
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00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
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