Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004201393

FEI Number

3004201393

Entity Name

3BY LTD.

City/State/Country

TEFEN Northern, IL

Establishment Address

BUILDING 14, Industrial Park, TEFEN Northern 2495900, IL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

3BY Ltd. (Owner Number: 9050049)

Owner / Operator Contact Address

Building 14, Industrial Park, PO Box 65, Tefen, IL-Z 2495900, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MP Vial Adapter 13MM Detachable holder and preattached Mixject Dispensing Pin with Vial Holder MIXJECT Mixject Dispensing Pin Mixject Dispensing Pin w/Detachable Vial Adaptor Vial Connector Needle Mixject; Preattached Vial Adaptor Vial2Bag Advanced® 20mm Admixture Device Healeon Duet Vial2Bag AdvancedTM 20mm Admixture Device Vial2Bag Advanced® 13mm Admixture Device Vented Vial Adapter Transfer Device Preattached Vial Adapter Needle MixJect Vial holder Mixject Dispensing pin with Detachable Vial Connector Detachable holder Modification to MIXject dispensing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2015-06-23
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-05-15
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-07-25
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-05-21
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2021-06-24
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-09-12
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-05-21
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2017-11-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2024-07-25
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-05-15
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2008-05-15

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

3BY 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
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

Similar Registrations

Registration Number	Establishment Name	Location
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004201393. Last updated year: 2026. Please use registration number 3004201393 when referencing this establishment in official correspondence.