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Ivenix Infusion System

FDA UDI

Class II (US FDA UDI)

by Fresenius Kabi

Identity

Trade Name
Ivenix Infusion System FDA UDI
Generic Name
Infusion pump medication-dosage application software FDA UDI
Device Name
Infusion Management System (IMS) FDA UDI
Model / Reference
030-0027-05 FDA UDI
Description
Infusion Management System (IMS) FDA UDI

Identifiers

Catalog Number
IMS FDA UDI
Primary DI / UDI-DI
00811050530399 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
Not 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

Ivenix Infusion System by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K183311 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fresenius Kabi

Sources (1)

  • FDA UDI 32f809d2-4ef5-4956-846a-bab0b67ec053 37 fields · synced Jun 1, 2026