Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612152

FEI Number

3002806901

Entity Name

ELCAM MEDICAL A.C.A.L.

City/State/Country

D.N. MEROM HAGALIL Northern, IL

Establishment Address

KIBBUTZ BAR-AM, D.N. MEROM HAGALIL Northern 1386000, 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

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

Registered Product Listings

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

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
3006891665	ELCAM MEDICAL ACAL	DALTON INDUSTRIAL PARK, P.O BOX 9 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 9612152. Last updated year: 2026. Please use registration number 9612152 when referencing this establishment in official correspondence.