Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010293992

FEI Number

3010293992

Entity Name

Eitan Medical LTD

City/State/Country

Netanya Central, IL

Establishment Address

29 Yad Haruzim St., Netanya Central 4250529, IL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Eitan Medical LTD (Owner Number: 10045422)

Owner / Operator Contact Address

29 Yad Haruzim St., Building 10, Netanya, IL-NOTA 4250529, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141834

PMA Number

N/A

All Registered Proprietary Names

Sapphire Sapphire Infusion Pump Sapphire Administration sets and accessories Sapphire Infusion Pump Administration Sets and Accessories Avoset infusion pump Needleless Y-Site Without Sleeve Epidural Set Syringe Set TPN 1.2 Filter Set Cartridge Set Subcutaneous Set Back Check Valve Set Vented/Non-vented Spike Avoset Cradle Extension Set Enteral Set Needleless Y-Site With Sleeve Avoset Cassette lock Sapphire Administration Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2017-06-26
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-06-26
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2020-11-25
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-11-25
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2020-11-25
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-11-14
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2023-11-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2023-11-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-11-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-12-16

Official Correspondent

Tally Eitan

US Agent Details

Rhona Shanker Business: Z & B Enterprises, Inc. Email: rhonashanker07@verizon.net Phone: (301) 2519570

Related Public Records

Same Entity

Eitan Medical LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

Similar Registrations

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3010223109	Synergy Health Ede BV	Etten Leur Noord-Brabant, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010293992. Last updated year: 2026. Please use registration number 3010293992 when referencing this establishment in official correspondence.