Identity
- Trade Name
- SJM MRI Activator™ FDA UDI
- Generic Name
- Multiple active implantable device programmer FDA UDI
- Device Name
- Handheld Device FDA UDI
- Model / Reference
- EX4000 FDA UDI
- Description
- Handheld Device FDA UDI
Identifiers
- Catalog Number
- EX4000 FDA UDI
- Primary DI / UDI-DI
- 05414734503648 FDA UDI
- PMA Number
- P140033 FDA UDI
- FDA Product Code
- LWP FDA UDI
- GMDN Term
- Multiple active implantable device programmer 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Multiple active implantable device programmer
SJM MRI Activator™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P140033 also covers:
- Assurity MRI™ — ST. JUDE MEDICAL, INC.
- Assurity MRI™ — ST. JUDE MEDICAL, INC.
- ENDURITY MRI™ — ST. JUDE MEDICAL, INC.
- ENDURITY MRI™ — ST. JUDE MEDICAL, INC.
- SJM MRI Activator™ — ST. JUDE MEDICAL, INC.
- Tendril MRI™ — ST. JUDE MEDICAL, INC.
- Tendril MRI™ — ST. JUDE MEDICAL, INC.
- Tendril MRI™ — ST. JUDE MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 42f147c4-2a67-45f9-a5d0-8a5b65cc6c3d 37 fields · synced Jun 6, 2026