GAMBRO RENAL PRODUCTS S.A. DE C.V.

FDA Device Registration & Listing · TIJUANA Baja California, MX · Registration 8030638

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
8030638
FEI Number
3002806727
Entity Name
GAMBRO RENAL PRODUCTS S.A. DE C.V.
City/State/Country
TIJUANA Baja California, MX
Establishment Address
BLVD PACIFICO 10014, PARQUE INDUSTRIAL PACIFICO, TIJUANA Baja California CP 22643, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Vantive US Healthcare LLC (Owner Number: 9038727)
Owner / Operator Contact Address
510 Lake Cook Road, Deerfield, IL 60015, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K070414
PMA Number
N/A

All Registered Proprietary Names

GAMBRO CARTRIDGE BLOOD SETS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2008-05-18

Official Correspondent

Jennifer Masek-Little

US Agent Details

Jennifer Masek-Little Business: Baxter Healthcare Corporation Email: jennifer.masek.little@vantive.com Phone: (815) 3548549

Related Public Records

Same Entity

Vantive US Healthcare 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
9610725 Vantive Manufacturing Limited CASTLEBAR, COUNTY MAYO Connaught, IE
9612168 Vantive Manufacturing Limited SWINFORD Mayo, IE
8010182 GAMBRO INDUSTRIES MEYZIEU CEDEX Rhone, FR
3030306055 Vantive US Healthcare LLC Deerfield, IL, US
3006755813 Bieffe Medital Manufacturing Oued Ellil Tunisia Oued Ellil Manouba, TN

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030638. Last updated year: 2026. Please use registration number 8030638 when referencing this establishment in official correspondence.
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