FDA.reportPublic FDA data

Globe® Platform

Primary DI
07540162100345
Brand
Globe® Platform
Company
Kardium Inc
Model
601-00066
Published
2025-09-15
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
false

Product Codes#

Code, Name table
CodeName
QWACardiovascular Delivery Catheter System Positioning And Stabilization Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWACardiovascular Delivery Catheter System Positioning And Stabilization DeviceCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540162100345PackageGS11In Commercial Distribution
07540162100338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540162100345075401621003457540162100345
07540162100338075401621003387540162100338

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac implantation catheter platform base, single-useA noninvasive, plate-like device designed to provide a flat surface on an operating table to support a platform on which is placed the holder of a cardiac implant delivery catheter during delivery of a cardiac implant. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
248480043
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
07540162100185Globe® Introducer601-010012025-09-15
07540162100239Globe Positioning System (GPS™) Cable601-000362025-09-15
07540162100253Globe Positioning System (GPS™) Electrodes601-000372025-09-15
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
07540162100369Globe® Catheter Cable Support601-000672025-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067035950MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067035967MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067035974MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
05415067046529MitraClip™ and TriClip™ST. JUDE MEDICAL, INC.QWA2026-03-30
07540162100338Globe® PlatformKardium IncQWA2025-09-15
07540162100352Globe® Catheter Cable SupportKardium IncQWA2025-09-15
07540162100369Globe® Catheter Cable SupportKardium IncQWA2025-09-15
00690103219494Edwards Reusable Rail ExtensionEdwards Lifesciences LLCQWA2025-07-09
00690103219500Edwards Reusable RailEdwards Lifesciences LLCQWA2025-07-09
00690103219579Edwards EVOQUE Stabilizer Edwards Lifesciences LLCQWA2025-07-09
00690103220001Edwards rail trayEdwards Lifesciences LLCQWA2025-07-09
00690103217278EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103217292EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103218015EdwardsEdwards Lifesciences LLCQWA2025-01-07
00690103217483EVOQUEEdwards Lifesciences LLCQWA2024-02-07
00690103217513EVOQUEEdwards Lifesciences LLCQWA2024-02-07
00690103217476EVOQUEEdwards Lifesciences LLCQWA2024-02-06
00690103217285EdwardsEdwards Lifesciences LLCQWA2023-07-10
00690103217308EdwardsEdwards Lifesciences LLCQWA2023-07-10
00690103218008EdwardsEdwards Lifesciences LLCQWA2023-07-10