Baxter Healthcare - Tel Aviv

FDA Device Registration & Listing · Tel Aviv, IL · Registration 3005004021

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
3005004021
FEI Number
3005004021
Entity Name
Baxter Healthcare - Tel Aviv
City/State/Country
Tel Aviv, IL
Establishment Address
2A Hashlosha St. F-32, Tel Aviv 6706055, IL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Repack or Relabel Medical Device
Owner / Operator
BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)
Owner / Operator Contact Address
One Baxter Parkway, Deerfield, IL 60015, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K012891
PMA Number
N/A

All Registered Proprietary Names

SunTech Cuff, All purpose general (Adult) SunTech Cuff, All purpose general (Adult Large) Passive Leg Raise Lift Reliant with SPo2 Cheetah Reliant Cheetah Nicom with NIBP Functionality Nicom Reliant with SPO2 Nicom Starling Monitor with SpO2 module Cheetah Nicom Nicom Reliant Cheetah Nicom Reliant Cheetah Starling SV Reliant Starling SV Starling Monitor Starling Fluid Management System Nicom – A Non-Invasive Cardiac Output Monitor Cheetah Nicom with NIBP and SpO2 Cheetah Nicom System NICOM Electrodes Prewired Electrode of Cheetah Medical Starling Sensors Electrode Cheetah Sensors Baxter Starling Sensor Pre-wired NICOM Sensor NICOM sensor OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) Nelcore Adult SpO2 sensor and Pulse Oximetry Interface Cable

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2023-12-06
INT Plinth Physical Medicine Class 1 890.3520 2026-06-03
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2022-11-16
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-11-16
DQA Oximeter Cardiovascular Class 2 870.2700 2022-11-16
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2022-11-16
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2023-12-06
DQA Oximeter Cardiovascular Class 2 870.2700 2023-12-06

Official Correspondent

Maha Nolasco

US Agent Details

Maha Nolasco Business: BAXTER HEALTHCARE CORPORATION Email: maha_nolasco@baxter.com Phone: (224) 2706181

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014226707 BARDY DIAGNOSTICS, INC. Bellevue, WA, US
3019257308 VIDEOMED SRL LIMENA Padova, IT
1314492 Baxter Healthcare Corporation MEDINA, NY, US
3007143268 Baxter Medical Systems GmbH + Co. KG SAALFELD Thuringia, DE
8010130 BAXTER SA LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K831001 Frontier Products UNICUFF-BLOOD PRESSURE CUFF 1983-07-28
K253089 Shenzhen Best Electronics Co., Ltd. NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) 2026-02-13
K972301 Rudolf Riester GmbH & Co. KG BIG BEN SQUARE, BIG BEN ROUND 1997-09-17
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

Similar Registrations

Registration Number Establishment Name Location
3031192529 Zhejiang LuDe Technology Development Co., Ltd. Wenzhou Zhejiang, CN
3002865611 BALLERSTEDT GMBH Reinbek Schleswig-Holstein, DE
3009154535 WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD. Wenzhou City Zhejiang, CN
1058002 Technicuff Corp. LEESBURG, FL, US
3001570235 GE Medical Systems Information Technologies, Inc. Waukesha, WI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005004021. Last updated year: 2026. Please use registration number 3005004021 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.