Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2248588

FEI Number

1000527169

Entity Name

GENESISBPS LLC

City/State/Country

Mahwah, NJ, US

Establishment Address

400 Corporate Dr, Mahwah, NJ 07430, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GENESISBPS LLC (Owner Number: 9020509)

Owner / Operator Contact Address

400 Corporate Dr, --, Mahwah, NJ 07430, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK950018

PMA Number

N/A

All Registered Proprietary Names

GENESIS RAPIDWELD STW Genesis RapidWeld II STW, model GRW-430-02 FLU-ADMIN I.V. Sets Genesis Tube Stripper Total Containment Device (TCD)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2015-03-19
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2022-07-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2009-11-17
KSQ	Device, Blood Mixing And Blood Weighing	Hematology	Class 1	864.9195	2000-10-24
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2008-10-13

Official Correspondent

Michele Kurus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GENESISBPS LLC

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.

Similar Registrations

Registration Number	Establishment Name	Location
9710609	RACER TECHNOLOGY PTE LTD	SINGAPORE South East, SG
3004548776	FENWAL, INC.	LAKE ZURICH, IL, US
3004634229	FRESENIUS HEMOCARE GMBH	Friedberg Hesse, DE
1722028	Terumo BCT, Inc..	Lakewood, CO, US
9681835	KOFU FACTORY OF TERUMO CORP.	NAKAKOMA-GUN Yamanashi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2248588. Last updated year: 2026. Please use registration number 2248588 when referencing this establishment in official correspondence.