Identity
- Trade Name
- Ivenix Infusion System FDA UDI
- Generic Name
- Bedside infusion pump, single-channel FDA UDI
- Device Name
- Large Volume Pump (LVP) Software (order 1 per pump), Version 3.0.0 FDA UDI
- Model / Reference
- 3.0.0 FDA UDI
- Description
- Large Volume Pump (LVP) Software (order 1 per pump), Version 3.0.0 FDA UDI
Identifiers
- Catalog Number
- LVP-SW-0002 FDA UDI
- Primary DI / UDI-DI
- 00811505030184 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Bedside infusion pump, single-channel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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: Bedside infusion pump, single-channel
Ivenix Infusion System by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Fresenius Kabi
Sources (1)
- FDA UDI 54ea4d52-c921-4caa-8c34-e804f43aadaa 35 fields · synced May 30, 2026