B. BRAUN US DEVICE MANUFACTURING LLC

FDA Device Registration & Listing · ALLENTOWN, PA, US · Registration 2523676

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2523676
FEI Number
2523676
Entity Name
B. BRAUN US DEVICE MANUFACTURING LLC
City/State/Country
ALLENTOWN, PA, US
Establishment Address
901 Marcon Blvd, ALLENTOWN, PA 18109, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
B. BRAUN MEDICAL INC. (Owner Number: 9925035)
Owner / Operator Contact Address
824 Twelfth Avenue, --, Bethlehem, PA 18018, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-01-30
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-03-21
FOX Stand, Infusion General Hospital Class 1 880.6990 1992-12-09
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2001-07-18
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2016-02-22
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2015-10-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
IWJ System, Applicator, Radionuclide, Manual Radiology Class 1 892.5650 2025-05-30
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2008-02-22
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-07-23
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2011-06-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-11-11
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2016-02-24
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2016-02-24
OGA Brachial Plexus Anesthesia Kit Anesthesiology Class 2 868.5140 2012-03-28
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2012-03-12
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2008-02-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-09-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 1992-08-27
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2008-02-04
OFU Spinal Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2012-12-14
LRS I.V. Start Kit General Hospital Class 2 880.5200 2014-01-07
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2008-02-22
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-21
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-09-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-09-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2016-09-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-02-22
FRN Pump, Infusion General Hospital Class 2 880.5725 2010-11-02
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2009-09-23
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2008-11-14
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2023-09-27
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2023-09-27
LCJ Tissue Expander And Accessories Unknown Class U N/A 2007-10-12
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 1999-06-04
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
BXN Stimulator, Nerve, Battery-Powered Anesthesiology Class 2 868.2775 2013-11-15
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2010-05-21
FMF Syringe, Piston General Hospital Class 2 880.5860 2011-06-29
LKK Pump, Infusion, Implanted, Programmable Unknown Class 3 N/A 2018-01-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-04-10
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2018-01-03
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2016-06-07
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2008-02-22
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2008-02-22
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2008-02-22
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2007-10-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-11-28
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2001-07-18
FMJ Manometer, Spinal-Fluid General Hospital Class 2 880.2500 2008-02-22
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2012-01-30
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
HRX Arthroscope Orthopedic Class 2 888.1100 2012-12-14
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2008-02-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-12-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2011-12-02
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
LKK Pump, Infusion, Implanted, Programmable Unknown Class 3 N/A 2013-01-18
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-08-28
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2001-07-18
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2020-08-19
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2010-12-18
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2013-04-09
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2008-02-22
EYI Adaptor, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2014-05-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-03-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2020-01-03
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2001-07-18
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2001-07-18
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2001-07-18
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2007-11-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-19
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2001-07-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-10-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2015-01-23
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2007-10-12
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2014-08-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2008-02-22
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2008-02-22
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2022-05-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-05-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-04-07
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2012-12-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2001-07-18
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-11-01
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2013-12-05
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 1999-06-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2008-05-30
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2009-09-24

Official Correspondent

Kamaal Anas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

B. BRAUN MEDICAL INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2021236 B. BRAUN US PHARMACEUTICAL MANUFACTURING LLC IRVINE, CA, US
2521402 B. BRAUN MEDICAL INC. BETHLEHEM, PA, US
9614279 B. BRAUN DOMINICAN REPUBLIC INC. SANTO DOMINGO Distrito Nacional, DO
3013764800 B. BRAUN MEDICAL INC. Allentown, PA, US

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-0003-06 B. Braun Medical, Inc. U
D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2523676. Last updated year: 2026. Please use registration number 2523676 when referencing this establishment in official correspondence.
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