Identity
- Trade Name
- Merlin™ FDA UDI
- Generic Name
- Implantable cardiac device management application software FDA UDI
- Device Name
- PCS 3330 Software Upgrade Kit FDA UDI
- Model / Reference
- 3330 FDA UDI
- Description
- PCS 3330 Software Upgrade Kit FDA UDI
Identifiers
- Catalog Number
- 3330 FDA UDI
- Primary DI / UDI-DI
- 05414734509725 FDA UDI
- FDA Product Code
- NIK FDA UDILWS FDA UDIOSR FDA UDINKE FDA UDIDXY FDA UDILWP FDA UDILWO FDA UDIPNJ FDA UDI
- GMDN Term
- Implantable cardiac device management application software FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.3610 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Implantable cardiac device management application software
Merlin™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 409fbc62-d6e7-40c2-9a51-8be6a805bee2 35 fields · synced Jun 6, 2026