Identity
- Trade Name
- MEDTRONIC CARELINK EXPRESS™ FDA UDI
- Generic Name
- Cardiac pulse generator reader, home-use FDA UDI
- Device Name
- MON 2020B1 CARELINK USA EXPRESS MONITOR FDA UDI
- Model / Reference
- 2020B1 FDA UDI
- Description
- MON 2020B1 CARELINK USA EXPRESS MONITOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994952400 FDA UDI
- PMA Number
- P890003 FDA UDI
- FDA Product Code
- OSR FDA UDI
- GMDN Term
- Cardiac pulse generator reader, home-use 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac pulse generator reader, home-use
Medtronic Carelink Express™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac pulse generator reader, home-use.
- CardioMessenger Smart 4G US mit WW Modem — BIOTRONIK SE & Co. KG · Class III
- CardioMessenger Smart 4G US — BIOTRONIK SE & Co. KG · Class III
- MyCareLink™ — MEDTRONIC, INC. · Class III
- MyCareLink™ — MEDTRONIC, INC. · Class III
- MyCareLink™ — MEDTRONIC, INC. · Class III
- MyCareLink™ — MEDTRONIC, INC. · Class III
- MyCareLink™ — MEDTRONIC, INC. · Class III
- CardioSight™ Reader — MEDTRONIC, 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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 1510cd69-ac72-49de-8feb-1360a4b44b82 36 fields · synced May 31, 2026