Identity
- Trade Name
- Connect FDA UDI
- Generic Name
- Patient health record information system FDA UDI
- Model / Reference
- Recorder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04033817901587 FDA UDI
- 510(k) Number
- K131816 FDA UDI
- FDA Product Code
- DXJ FDA UDI
- GMDN Term
- Patient health record information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2450 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: Patient health record information system
Connect by LivaNova Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ELI Edit — MORTARA INSTRUMENT, INC. · Class II
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- Mural Clinical Viewer — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · Class II
- Xper Information Management System — Philips Medical Systems Nederland B.V. · Class II
Cleared under the same submission
K131816 also covers:
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
- LivaNova Deutschland GmbH
Sources (1)
- FDA UDI 6d7b8f77-a11b-4b78-9637-fb3989ee15e4 33 fields · synced Jun 1, 2026