Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681240

FEI Number

3007033498

Entity Name

B. Braun Avitum Italy S.p.A.

City/State/Country

MIRANDOLA Modena, IT

Establishment Address

VIA XXV LUGLIO 11, MIRANDOLA Modena 41037, IT

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

B. BRAUN Avitum AG (Owner Number: 9057188)

Owner / Operator Contact Address

Schwarzenberger Weg 73-79, --, MELSUNGEN, DE-NOTA D-34212, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K041415

PMA Number

N/A

All Registered Proprietary Names

EVA Dual Chamber Mixing Container for use w/ Apex Compounding System EVA Dual Chamber Mixing Container for use w/ Pinnacle TPN Management Systems High Flow Y-Adapter Transfer set w/ Pinnacle TPN Management System Tamper Resistant Clamp EVA Mixing Container for use with Gravity Transfer High Flow Y-Adapter EVA Mixing Container for use with Apex Compounding System EVA mixing Container for use w/ Pinnacle TPN Management System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2008-03-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-10-24
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2007-10-24

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: B. BRAUN MEDICAL, INC. Email: kamaal.anas@bbraunusa.com Phone: (484) 5231349

Related Public Records

Same Entity

B. BRAUN Avitum 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
3007007791	B. BRAUN AVITUM AG	MELSUNGEN Hesse, DE
3004201412	B. Braun Avitum Saxonia GmbH	RADEBERG Saxony, DE
3014300273	B.Braun Avitum Saxonia GmbH	Wilsdruff Saxony, DE
3002879653	B. Braun Avitum AG	MELSUNGEN Hesse, DE
3004176176	B. Braun Avitum AG	GLANDORF Lower Saxony, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0004-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0005-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681240. Last updated year: 2026. Please use registration number 9681240 when referencing this establishment in official correspondence.