Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1410248

FEI Number

1410248

Entity Name

CSL Behring LLC

City/State/Country

Bradley, IL, US

Establishment Address

1201 N Kinzie Ave, Bradley, IL 60915, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

CSL Behring LLC (Owner Number: 10042341)

Owner / Operator Contact Address

1020 First Avenue, PO Box 61501, King of Prussia, PA 19406, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133867

PMA Number

N/A

All Registered Proprietary Names

Nipro SafeTouch PSV Scalp Vein Set with Safety Device Safety Glide Needle Surflo Winged Infusion Set with Needle Protection (Surshield)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2014-02-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-12-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-12-07

Official Correspondent

Matthew McCaslin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CSL Behring 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
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1410248. Last updated year: 2026. Please use registration number 1410248 when referencing this establishment in official correspondence.