Globe Positioning System (GPS™) Cable

GUDID 07540162100246

Kardium Inc

Electrical-only medical device connection cable, reusable
Primary Device ID07540162100246
NIH Device Record Key633778de-72d9-4059-ac40-7833eae6cb1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlobe Positioning System (GPS™) Cable
Version Model Number601-00036
Company DUNS248480043
Company NameKardium Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107540162100239 [Primary]
GS107540162100246 [Package]
Contains: 07540162100239
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-23
Device Publish Date2025-09-15

Devices Manufactured by Kardium Inc

07540162100154 - Globe® Catheter2025-09-23
07540162100192 - Globe® Introducer2025-09-23
07540162100246 - Globe Positioning System (GPS™) Cable2025-09-23
07540162100246 - Globe Positioning System (GPS™) Cable2025-09-23
07540162100260 - Globe Positioning System (GPS™) Electrodes2025-09-23
07540162100284 - Globe® Catheter Cable2025-09-23
07540162100215 - Globe® Controller2025-09-23
07540162100314 - Globe® Workstation2025-09-23
07540162100222 - Globe® PF Generator2025-09-23

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