B. BRAUN MEDICAL INC.

FDA Device Registration & Listing · BETHLEHEM, PA, US · Registration 2521402

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
2521402
FEI Number
2521402
Entity Name
B. BRAUN MEDICAL INC.
City/State/Country
BETHLEHEM, PA, US
Establishment Address
824 12th Ave, BETHLEHEM, PA 18018, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
B. BRAUN MEDICAL INC. (Owner Number: 9925035)
Owner / Operator Contact Address
824 Twelfth Avenue, --, Bethlehem, PA 18018, US
Initial Importer Flag
Y
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
FMJ Manometer, Spinal-Fluid General Hospital Class 2 880.2500 2008-02-22
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2015-10-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2016-06-07
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2007-11-09
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2001-07-18
LRS I.V. Start Kit General Hospital Class 2 880.5200 2014-01-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-07-23
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
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2008-11-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-04-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2011-12-02
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2001-07-18
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
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2008-02-22
MRZ Accessories, Pump, Infusion General Hospital Class 2 880.5725 2018-08-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-01-13
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2015-03-06
OGJ Nerve Block Tray Anesthesiology Class 2 868.5140 2012-03-28
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2001-07-18
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2020-08-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
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
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2023-09-27
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2023-09-27
OFU Spinal Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2001-07-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-11-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
FRN Pump, Infusion General Hospital Class 2 880.5725 2010-11-02
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2008-02-22
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2016-02-29
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-11-11
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
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
OGA Brachial Plexus Anesthesia Kit Anesthesiology Class 2 868.5140 2012-03-28
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2007-10-24
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
KPE Container, I.V. General Hospital Class 2 880.5025 2007-10-16
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2007-09-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
MON System, Hemodialysis, Remote Accessories Gastroenterology, Urology Class 1 876.5820 2020-07-08
OXQ Dressing Change Tray General Hospital Class 1 880.5075 2015-03-09
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
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 1993-12-29
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 1999-06-04
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 1999-06-04
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2010-12-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
LCJ Tissue Expander And Accessories Unknown Class U N/A 2007-10-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 1992-08-27
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2010-08-05
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2007-10-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-05-15
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2013-01-29
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2012-01-30
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
FOX Stand, Infusion General Hospital Class 1 880.6990 1992-12-09

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
9614279 B. BRAUN DOMINICAN REPUBLIC INC. SANTO DOMINGO Distrito Nacional, DO
3013764800 B. BRAUN MEDICAL INC. Allentown, PA, US
2523676 B. BRAUN US DEVICE MANUFACTURING LLC ALLENTOWN, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
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.

Similar Registrations

Registration Number Establishment Name Location
9611612 PAJUNK GMBH MEDIZINTECHNOLOGIE GEISINGEN Baden-Wurttemberg, DE
2523676 B. BRAUN US DEVICE MANUFACTURING LLC ALLENTOWN, PA, US
2029015 Sterigenics U.S., LLC Ontario, CA, US
2433012 BUSSE HOSPITAL DISPOSABLES HAUPPAUGE, NY, US
3013764800 B. BRAUN MEDICAL INC. Allentown, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2521402. Last updated year: 2026. Please use registration number 2521402 when referencing this establishment in official correspondence.
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