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Globe Positioning System (GPS™) Electrodes

FDA UDI

Class II (US FDA UDI)

by Kardium, Inc.

Identity

Trade Name
Globe Positioning System (GPS™) Electrodes FDA UDI
Generic Name
Cardiac mapping system reference patch FDA UDI
Model / Reference
601-00037 FDA UDI

Identifiers

Primary DI / UDI-DI
07540162100253 FDA UDI
510(k) Number
K250747 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac mapping system reference patch FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiac mapping system reference patch

Globe Positioning System (GPS™) Electrodes by Kardium, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system reference patch.

Cleared under the same submission

K250747 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kardium, Inc.

Sources (1)

  • FDA UDI fc568308-35b8-45df-a0d8-bf10fe1589b9 33 fields · synced May 30, 2026