Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611423

FEI Number

3002807615

Entity Name

SIMPLIVIA HEALTHCARE LTD.

City/State/Country

KIRYAT SHMONA Northern, IL

Establishment Address

NORTH IND. ZONE P.O.BOX 888, KIRYAT SHMONA Northern 1101801, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIMPLIVIA HEALTHCARE LTD. (Owner Number: 9001925)

Owner / Operator Contact Address

North Ind. Zone, (Simplivia plant), North Ind. Zone P.O.Box 888, Kiryat Shmona, IL-NOTA 1101801, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201142

PMA Number

N/A

All Registered Proprietary Names

OnGuard2 Catheter Adaptor OnGuard2 Secondary IV set OnGuard Closed Adaptor SP OnGuard2 Closed Y Inline Set OnGuard2 Bag Adaptor CP OnGuard®2 Luer Lock Adaptor Chemfort Sterile Caps for Syringe OnGuard®2 20mm Vial Adaptor and 13mm Convertor II OnGuard®2 Bag Adaptor SP II OnGuard®2 Bag Adaptor SP Chemfort 20mm Vial Adaptor II and 13mm convertor OnGuard®2 Syringe Adaptor OnGuard®2 Syringe Adaptor Lock II OnGuard®2 28mm Vial Adaptor OnGuard®2 20mm Vial Adaptor SL and 13mm Convertor OnGuard Spike Port Adaptor OnGuard®2 Female Luer Lock Adaptor OnGuard2 Bag Adaptor LL with ULTRASITE OnGuard2 Bag Adaptor LL OnGuard2 IV Secondary Safety Onguard2 Bag Adaptor SPT OnGuard2 IV Secondary Safety Set with ULTRASITE OnGuard2 Bag Adaptor SP with ULTRASITE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2023-09-07
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2021-10-07
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2020-05-19
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2015-11-04
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2025-08-06
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	General Hospital	Class 2	880.5440	2021-03-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-03-09

Official Correspondent

Anat Coyle

US Agent Details

Stephen H. Lieberman Business: DONAWA CONSULTING LLC Email: lieberman@donawa.com Phone: (561) 3020777

Related Public Records

Same Entity

SIMPLIVIA HEALTHCARE 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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611423. Last updated year: 2026. Please use registration number 9611423 when referencing this establishment in official correspondence.