Identity
- Trade Name
- AVEIR™ FDA UDI
- Generic Name
- Transtelephonic implantable pacemaker analysis system FDA UDI
- Device Name
- Patient Transmitter Software FDA UDI
- Model / Reference
- LSRM1000 FDA UDI
- Description
- Patient Transmitter Software FDA UDI
Identifiers
- Catalog Number
- LSRM1000 FDA UDI
- Primary DI / UDI-DI
- 05415067049971 FDA UDI
- PMA Number
- P150035 FDA UDI
- FDA Product Code
- PNJ FDA UDI
- GMDN Term
- Transtelephonic implantable pacemaker analysis system 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transtelephonic implantable pacemaker analysis system
Aveir™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Transtelephonic implantable pacemaker analysis system.
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- AVEIR™ — ST. JUDE MEDICAL, INC. · Class III
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Cleared under the same submission
P150035 also covers:
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 f6b3b4a2-9d22-4200-8ce3-9eb72ebab291 36 fields · synced May 30, 2026