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Axium™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Axium™ FDA UDI
Generic Name
Medical bag FDA UDI
Device Name
Programmer Carrying Case For use with Patient Programmer MN10600-02 FDA UDI
Model / Reference
MN13500-S FDA UDI
Description
Programmer Carrying Case For use with Patient Programmer MN10600-02 FDA UDI

Identifiers

Catalog Number
MN13500-S FDA UDI
Primary DI / UDI-DI
05415067025661 FDA UDI
PMA Number
P150004 FDA UDI
FDA Product Code
PMP FDA UDI
GMDN Term
Medical bag FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Medical bag

Axium™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical bag.

Cleared under the same submission

P150004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI 3017783e-1b52-44d5-9355-4d0f3971c92f 37 fields · synced May 30, 2026