Identity
- Trade Name
- AngelMed Guardian IMD Model AMSG3-E FDA UDI
- Generic Name
- Implantable cardiac monitor FDA UDI
- Device Name
- IMD AMSG3-E Kit FDA UDI
- Model / Reference
- 0212-2100-001#P16 FDA UDI
- Description
- IMD AMSG3-E Kit FDA UDI
Identifiers
- Catalog Number
- 0212-2100-001#P16 FDA UDI
- Primary DI / UDI-DI
- 00850012625001 FDA UDI
- PMA Number
- P150009 FDA UDI
- FDA Product Code
- QBI FDA UDI
- GMDN Term
- Implantable cardiac monitor FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Implantable cardiac monitor
AngelMed Guardian IMD Model AMSG3-E by Avertix Medical Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable cardiac monitor.
- Jot Dx™ — ST. JUDE MEDICAL, INC. · Class II
- LUX-Dx™ Insertable Cardiac Monitor — Boston Scientific · Class II
- Reveal LINQ™ Insertion Tools — MEDTRONIC, INC. · Class II
- LINQ II™ — MEDTRONIC, INC. · Class II
- BioMonitor IV — BIOTRONIK SE & Co. KG · Class II
- LUX-Dx II+™ — Boston Scientific · Class II
- Confirm Rx™ — ST. JUDE MEDICAL, INC. · Class II
- LUX-Dx II™ — Boston Scientific · Class II
Cleared under the same submission
P150009 also covers:
- AngelMed Guardian EXD Carrying Case — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Lanyard — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 Battery — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 Battery, 10 Pack — AVERTIX MEDICAL INC.
- AngelMed Guardian EXD Model EXD-001 Battery, 30 Pack — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer Application User's Manual CD — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer External Power Accessories — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer Model PROG-003 — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer PROG-003 Carrying Case — AVERTIX MEDICAL INC.
- AngelMed Guardian Programmer Serial Cable, 10 Foot — AVERTIX 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
- Avertix Medical Inc.
Sources (1)
- FDA UDI 97eddb46-2673-4d5a-a924-f945c231d2cf 35 fields · synced Jun 1, 2026