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Globe® Catheter

FDA UDI

Class III (US FDA UDI)

by Kardium, Inc.

Identity

Trade Name
Globe® Catheter FDA UDI
Generic Name
Cardiac irreversible electroporation system catheter FDA UDI
Model / Reference
601-01000 FDA UDI

Identifiers

Primary DI / UDI-DI
07540162100154 FDA UDI
PMA Number
P240044 FDA UDI
FDA Product Code
QZI FDA UDI
GMDN Term
Cardiac irreversible electroporation system catheter FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiac irreversible electroporation system catheter

Globe® Catheter by Kardium, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac irreversible electroporation system catheter.

Cleared under the same submission

P240044 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 e13e01b4-37d5-4195-b6fb-0dfe2819de56 33 fields · synced May 31, 2026