BAXTER S.A. DE C.V.

FDA Device Registration & Listing · CIVAC, JIUTEPEC, MORELOS, MX · Registration 8030639

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
8030639
FEI Number
6898
Entity Name
BAXTER S.A. DE C.V.
City/State/Country
CIVAC, JIUTEPEC, MORELOS, MX
Establishment Address
AV. DE LOS 50 METROS NO. 2, CIVAC, JIUTEPEC, MORELOS 62578, 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
K152129
PMA Number
N/A

All Registered Proprietary Names

PRISMASATE GAMBRO CARTRIDGE BLOOD SETS POLYFLUX 140H, 170H, 210H POLYFLUX 14L, 17L, 21L MiniCap with Povidone-Iodine Solution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2008-05-18
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2008-05-18
MSF Hemodialyzer, Re-Use, High Flux Gastroenterology, Urology Class 2 876.5860 2007-03-21
FJI Dialyzer, Capillary, Hollow Fiber Gastroenterology, Urology Class 2 876.5820 2007-03-21
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2007-03-21
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2024-11-18

Official Correspondent

Jennifer Masek-Little

US Agent Details

Jennifer Masek-Little Business: Vantive US Healthcare LLC 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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K864831 Cobe Laboratories, Inc. COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS 1987-03-27
K772290 Redy Laboratories DIALYZER, CAPILATORY, HOLLOW FIBER 1978-03-15
K811830 Cordis Corp. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 1981-09-21
K070320 Edwards Lifesciences Services GmbH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 2007-06-07
K150880 Outset Medical Tablo Console with Wireless Capability 2015-05-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-2026 Fresenius Medical Care Holdings, Inc. 2
Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
Z-0019-2025 Outset Medical, Inc. 2
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis SYS, with CDX
Z-0029-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System without CDX
Z-0030-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System w/Bibag

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9616277 S.M.A.D. L'ARBRESLE Rhone, FR
3027241826 RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V. El Marques Queretaro, MX
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030639. Last updated year: 2026. Please use registration number 8030639 when referencing this establishment in official correspondence.
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