Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004102635

FEI Number

3004102635

Entity Name

METRIX DOMINICANA S.R.L.

City/State/Country

HAINA San Cristobal, DO

Establishment Address

PARQUE INDUSTRIAL ITABO, S.A. (PIISA), BULIDING 5, HAINA San Cristobal --, DO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

The Metrix Company (Owner Number: 1937141)

Owner / Operator Contact Address

4400 Chavenelle Rd, --, Dubuque, IA 52002, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030888

PMA Number

N/A

All Registered Proprietary Names

HCT Baxter Healthcare Corporation A6001 - 5L EFFLUENT BAG GAMBRO UF Solutions, Inc. A6001 - 5 L Effluent Bag BAXTER HEALTHCARE CORPORATION ExactaMix SECURE IMed Products VYGON MSD CORMIX SECURE

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	2020-10-23
MON	System, Hemodialysis, Remote Accessories	Gastroenterology, Urology	Class 1	876.5820	2015-01-27
KPE	Container, I.V.	General Hospital	Class 2	880.5025	1997-06-19
KPE	Container, I.V.	General Hospital	Class 2	880.5025	1997-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

Mike Regan Business: The Metrix Company Email: quality@metrixco.com Phone: (563) 5568800

Related Public Records

Same Entity

The Metrix Company

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1937141	THE METRIX COMPANY	DUBUQUE, IA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K041415	B.Braun Medical, Inc.	EVA TPN CONTAINER	2004-08-04

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.

Similar Registrations

Registration Number	Establishment Name	Location
3004181163	CGR Minnesota LLC	Inver Grove Heights, MN, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US
3000268902	IMPERIAL TRADING LIMITED	Bridgetown Saint Michael, BB
2025816	ICU MEDICAL, INC.	SAN CLEMENTE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004102635. Last updated year: 2026. Please use registration number 3004102635 when referencing this establishment in official correspondence.