Identity
- Trade Name
- PACEART® SYSTEM ECG MODULE FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- ECG P127TUV PACEART SYSTEM FW 1.09 GLBL FDA UDI
- Model / Reference
- P127TUV FDA UDI
- Description
- ECG P127TUV PACEART SYSTEM FW 1.09 GLBL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994546180 FDA UDI
- 510(k) Number
- K024278 FDA UDI
- FDA Product Code
- DPS FDA UDIDXH FDA UDIKRE FDA UDI
- GMDN Term
- Patient health record information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI870.2920 FDA UDI870.3640 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: Patient health record information system application software
Paceart® System Ecg Module by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K024278 also covers:
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III — MEDTRONIC, INC.
- PACEART® SYSTEM GET CONNECTED III, CardioVoice® TTM Assistant Software — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 8ffcc8e3-82d9-48fe-81ac-2b5e55cb55d7 36 fields · synced May 30, 2026