Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014732157

FEI Number

3014732157

Entity Name

Fresenius Kabi USA, LLC

City/State/Country

North Andover, MA, US

Establishment Address

50 High Street, Suite 50, North Andover, MA 01845, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Fresenius Kabi AG (Owner Number: 9027285)

Owner / Operator Contact Address

Else-Kroner-Str. 1, 61352 Bad Homburg, DE-NOTA NONE, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213089

PMA Number

N/A

All Registered Proprietary Names

Ivenix Infusion System (IIS) Ivenix Infusion System (IIS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2022-05-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-04
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2022-05-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fresenius Kabi AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004634229	FRESENIUS HEMOCARE GMBH	Friedberg Hesse, DE
9611902	Fenwal France S.A.S.	Lacs Indre, FR
9681819	FRESENIUS KABI DEUTSCHLAND GMBH	BAD HERSFELD Hesse, DE
3008810357	Clinico Medical Sp. z o.o.	Blonie/Miekinia Dolnoslaskie, PL
3005778453	FRESENIUS KABI WARRENDALE	WARRENDALE, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2023	Fresenius Kabi USA, LLC	2	Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014732157. Last updated year: 2026. Please use registration number 3014732157 when referencing this establishment in official correspondence.