Identity
- Trade Name
- Ivenix Infusion System FDA UDI
- Generic Name
- Infusion pump medication-dosage application software FDA UDI
- Device Name
- Infusion Management System (IMS), version 4.0.0 FDA UDI
- Model / Reference
- 4.0.0 FDA UDI
- Description
- Infusion Management System (IMS), version 4.0.0 FDA UDI
Identifiers
- Catalog Number
- IMS-0700 FDA UDI
- Primary DI / UDI-DI
- 00811505030351 FDA UDI
- 510(k) Number
- K183311 FDA UDI
- FDA Product Code
- PHC FDA UDI
- GMDN Term
- Infusion pump medication-dosage application software 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: Infusion pump medication-dosage application software
Ivenix Infusion System by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183311 also covers:
- Ivenix Infusion System — Fresenius Kabi
- Ivenix Infusion System — Fresenius Kabi
- Ivenix Infusion System — Fresenius Kabi
- Ivenix Infusion System — Fresenius Kabi
- Ivenix Infusion System — Fresenius Kabi
- Ivenix Infusion System — Fresenius Kabi
- Ivenix Infusion System — Fresenius Kabi
- Ivenix Infusion System — Fresenius Kabi
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 e65312c2-b01f-414d-826d-741d7bfd107f 36 fields · synced May 30, 2026