Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681819

FEI Number

3000147578

Entity Name

FRESENIUS KABI DEUTSCHLAND GMBH

City/State/Country

BAD HERSFELD Hesse, DE

Establishment Address

5 ROBERT-KOCH-STRASSE, BAD HERSFELD Hesse D-36251, DE

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

K121613

PMA Number

N/A

All Registered Proprietary Names

Volumat Line freeflex+ Transfer Adapter Transfer Set VOLUMAT MC AGILIA VOLUMAT LINES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-02-28
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-11-16
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2022-11-28
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-05-23

Official Correspondent

No official correspondent registered.

US Agent Details

Rhoda Lynn Valera Email: rhoda.valera@fresenius-kabi.com Phone: (847) 5502929

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
3014732157	Fresenius Kabi USA, LLC	North Andover, MA, US
3004634229	FRESENIUS HEMOCARE GMBH	Friedberg Hesse, DE
9611902	Fenwal France S.A.S.	Lacs Indre, FR
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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681819. Last updated year: 2026. Please use registration number 9681819 when referencing this establishment in official correspondence.