Baja Fur S.A. de C.V.

FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3017552925

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
3017552925
FEI Number
3017552925
Entity Name
Baja Fur S.A. de C.V.
City/State/Country
Tijuana Baja California, MX
Establishment Address
C. Vecinal #20601, Modulos J y K Col. Presa Rodriguez, Tijuana Baja California C.P. 22124, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Outset Medical, Inc. (Owner Number: 10047467)
Owner / Operator Contact Address
3052 Orchard Drive, San Jose, CA 95134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233335
PMA Number
N/A

All Registered Proprietary Names

Tablo® Hemodialysis System Tablo Hemodialysis System Tablo® Hemodialysis System Tablo® Cartridge Tablo® Hemodialysis System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2023-09-07
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2023-09-07
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2026-06-19
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2026-06-19
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2020-01-08
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2020-01-08
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2020-01-08
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2021-11-29
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-01-31
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2024-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

Dinamarie Stefani Business: Outset Medical, Inc. Email: dstefani@outsetmedical.com Phone: (669) 2318200

Related Public Records

Same Entity

Outset Medical, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038138522 Baja Fur S.A. de C.V. Tijuana BC. Baja California, MX
3010355846 Outset Medical, Inc. San Jose, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0031-2024 Fresenius Medical Care Holdings, Inc. 2
2008T GEN 2 Bibag without CDX

Similar Registrations

Registration Number Establishment Name Location
3015349756 DIALITY, INC. Irvine, CA, US
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
3012149633 LIDER MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR
3005695808 SARMED SRL IGLESIAS Sardegna, IT
3007137787 Nuwellis, Inc. Eden Prairie, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017552925. Last updated year: 2026. Please use registration number 3017552925 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.