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Globe® Platform

FDA UDI

Class I (US FDA UDI)

by Kardium, Inc.

Identity

Trade Name
Globe® Platform FDA UDI
Generic Name
Cardiac implantation catheter platform base, single-use FDA UDI
Model / Reference
601-00066 FDA UDI

Identifiers

Primary DI / UDI-DI
07540162100338 FDA UDI
FDA Product Code
QWA FDA UDI
GMDN Term
Cardiac implantation catheter platform base, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.3955 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac implantation catheter platform base, single-use

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

Similar devices

Also classified as Cardiac implantation catheter platform base, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kardium, Inc.

Sources (1)

  • FDA UDI 98d30818-d0a7-4b44-895c-6a1a46b0a7ff 32 fields · synced May 30, 2026