Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023981687

FEI Number

3008730267

Entity Name

Erika of Texas

City/State/Country

Pharr, TX, US

Establishment Address

900 W Zaragosa Dr., Suite D, Pharr, TX 78577, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fresenius Medical Care Renal Therapies Group, LLC (Owner Number: 9030510)

Owner / Operator Contact Address

920 WINTER STREET, --, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141997

PMA Number

N/A

All Registered Proprietary Names

CritLine IV System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2015-04-29

Official Correspondent

Rachel Lloyd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fresenius Medical Care Renal Therapies Group, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012364195	Fresenius Medical Care de Mexico	Zapopan Jalisco, MX
3031565407	Erika de Reynosa, S.A. de C.V.	CD, Reynosa Tamaulipas, MX
3005578748	Haemotec, a division of Fresenius Medical Care Canada Inc.	VAUDREUIL-DORION Quebec, CA
3013546115	Fresenius USA Manufacturing, Inc.	Knoxville, TN, US
3005162618	Fresenius USA Manufacturing, Inc.	OREGON, OH, US

Similar Registrations

Registration Number	Establishment Name	Location
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
8030665	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
3003464075	NXSTAGE MEDICAL, INC.	LAWRENCE, MA, US
3027859369	M.E.Nikkiso Vietnam Co., Ltd.	Quang Ngai, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023981687. Last updated year: 2026. Please use registration number 3023981687 when referencing this establishment in official correspondence.