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AngelMed Guardian Programmer Application User's Manual CD
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- AngelMed Guardian Programmer Application User's Manual CD FDA UDI
- Generic Name
- Implantable cardiac device management application software FDA UDI
- Device Name
- PROG-003 Application User's Manual CD FDA UDI
- Model / Reference
- 0204-2100-073#P16 FDA UDI
- Description
- PROG-003 Application User's Manual CD FDA UDI
Identifiers
- Catalog Number
- 0204-2100-073#P16 FDA UDI
- Primary DI / UDI-DI
- 00850012625131 FDA UDI
- PMA Number
- P150009 FDA UDI
- FDA Product Code
- QBI FDA UDI
- GMDN Term
- Implantable cardiac device management application software 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
No
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
No
FDA UDI
Category: Implantable cardiac device management application software
AngelMed Guardian Programmer Application User's Manual CD by Avertix Medical Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable cardiac device management application software.
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- CareLink SmartSync™ PSA Application — MEDTRONIC, INC. · Class II
- Merlin™ — ST. JUDE MEDICAL, INC. · Class III
- Reveal LINQ™ Mobile Manager — MEDTRONIC, INC. · Class II
- AccuRhythm™ AI — MEDTRONIC, INC. · Class II
- myLUX™ Patient Kit with mobile device — Boston Scientific · Class II
- LUX-Dx™ Clinic Assistant Kit with mobile device — 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 IMD Model AMSG3-E — 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 2715c78b-d856-4290-aba4-af73eeae506a 35 fields · synced May 29, 2026