Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006891665

FEI Number

3006891665

Entity Name

ELCAM MEDICAL ACAL

City/State/Country

DALTON INDUSTRIAL PARK, P.O BOX 9 Northern, IL

Establishment Address

D.N. MEROM HAGALIL, DALTON INDUSTRIAL PARK, P.O BOX 9 Northern 1381000, IL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Elcam Medical ACAL (Owner Number: 8030082)

Owner / Operator Contact Address

Kibbutz BarAm, D.N Merom Hagalil, IL-Z 1386000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

D600 Discofix ® High Flow Stopcock Elcam Stopcocks and Manifolds with improved blister Elcam Stopcocks and Manifolds DISPOSABLE TRANSPAC(R) ML INTEGRATE SafePort I&S Manifold (or Stopcock), Stopcocks and Manifolds Y-Click Connector Marvelous Closed Stopcock and MRVLS Ultraport High Flow Stopcock ULTRAPORT zer0 High Flow Stopcock H-Flow Valve Elcam Stopcocks and Manifolds with Safe2 Rotator A-TAP Transducer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2020-04-13
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2006-11-20
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-03-31
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-03-31
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2002-03-28
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-03-31
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-03-30
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2014-12-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-08-01
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2013-01-17

Official Correspondent

Yaniv Menachem

US Agent Details

Tomer Gil Business: ELCAM MEDICAL INC. Email: tomer@elcam.co.il Phone: (201) 4571120

Related Public Records

Same Entity

Elcam Medical ACAL

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9612152	ELCAM MEDICAL A.C.A.L.	D.N. MEROM HAGALIL Northern, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006891665. Last updated year: 2026. Please use registration number 3006891665 when referencing this establishment in official correspondence.