FENWAL INTERNATIONAL, INC.

FDA Device Registration & Listing · San German, PR, US · Registration 2648979

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2648979
FEI Number
1000222291
Entity Name
FENWAL INTERNATIONAL, INC.
City/State/Country
San German, PR, US
Establishment Address
CAMINO REAL INDUSTRIAL PARK,, ROAD No. 122, San German, PR 00683, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ALYX 2RBC-LR Kit Alyx Component Collection System AMICUS SEPARATOR SYSTEM ALYX Component Collection System ALYX 2 RBC-LR Kit ALYX Component Collection System Alyx Component Collection System Alyx Red Cell Kit LOVO Med Cell Processing System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2024-04-24
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2020-07-09
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-10-16
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2017-04-26
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2018-05-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9681819 FRESENIUS KABI DEUTSCHLAND GMBH BAD HERSFELD Hesse, DE
3008810357 Clinico Medical Sp. z o.o. Blonie/Miekinia Dolnoslaskie, PL

Similar Registrations

Registration Number Establishment Name Location
3014982186 JMS HEALTHCARE PHL, INC. Tanauan City Batangas, PH
3008816814 MEDICAL TECHNOLOGIES INNOVATORS, INC Miami, FL, US
3032902763 BGS US LLC Imperial, PA, US
3004601221 Comar Rancho Cucamonga, CA, US
3010273872 Synergy Health AST, SRL Alajuela, CR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648979. Last updated year: 2026. Please use registration number 2648979 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.