Identity
- Trade Name
- CareLink Express™ Mobile System FDA UDI
- Generic Name
- Implantable cardiac device management application software FDA UDI
- Device Name
- SW 31302 CARELINK EXPRESS MOBILE IOS USA FDA UDI
- Model / Reference
- 31302 FDA UDI
- Description
- SW 31302 CARELINK EXPRESS MOBILE IOS USA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169636668 FDA UDI
- PMA Number
- P890003 FDA UDI
- FDA Product Code
- OSR 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
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
No
FDA UDI
Category: Implantable cardiac device management application software
CareLink Express™ Mobile System by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable cardiac device management application software.
- Home Monitoring Service Center — BIOTRONIK SE & Co. KG · Class III
- AngelMed Guardian Programmer Application User's Manual CD — AVERTIX MEDICAL INC. · Class III
- Merlin™ — ST. JUDE MEDICAL, INC. · Class III
- AngelMed Guardian Programmer External Power Accessories — AVERTIX MEDICAL INC. · Class III
- AngelMed Guardian Programmer PROG-003 Carrying Case — AVERTIX MEDICAL INC. · Class III
- myLUX™ Patient Kit with mobile device — Boston Scientific · Class II
- LUX-Dx™ Clinic Assistant Kit with mobile device — Boston Scientific · Class II
- myMerlinPulse™ — ST. JUDE MEDICAL, INC. · Class III
Cleared under the same submission
P890003 also covers:
- CAPSURE® VDD-2 — MEDTRONIC, INC.
- CARELINK® MONITOR — MEDTRONIC, INC.
- CardioSight™ Reader — MEDTRONIC, INC.
- CareLink SmartSync™ PSA Application — MEDTRONIC, INC.
- Instrument Command Library — MEDTRONIC, INC.
- Medtronic CareLink® Programmer — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, INC.
- MyCareLink™ — MEDTRONIC, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 14d7334c-a591-47a9-b70b-f0085d4ff9b0 35 fields · synced May 31, 2026