Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807257

FEI Number

3002807257

Entity Name

LABORATORIOS GRIFOLS, S.A.

City/State/Country

PARETS DEL VALLES Barcelona, ES

Establishment Address

POL. LEVANTE C/CAN GUASCH, 2, PARETS DEL VALLES Barcelona 08150, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LABORATORIOS GRIFOLS, S.A. (Owner Number: 9056285)

Owner / Operator Contact Address

POL. LEVANTE C/CAN GUASCH, 2, PARETS DEL VALLES, ES-B 08150, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GRI-FILL 6 to 1 Set Gri-Fill Peristaltic Set GRI-BAG Gri-fill

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2010-04-06
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2017-11-08
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2007-12-20
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2007-12-20
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2007-12-20
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2005-04-25

Official Correspondent

No official correspondent registered.

US Agent Details

Alisha McReynolds Business: Grifols Diagnostic Solutions Inc. Email: alisha.mcreynolds@grifols.com Phone: (510) 9235046

Related Public Records

Same Entity

LABORATORIOS GRIFOLS, S.A.

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

View Entity Profile →

Related 510(k) Records

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807257. Last updated year: 2026. Please use registration number 3002807257 when referencing this establishment in official correspondence.