B. BRAUN MEDICAL INC.

FDA Device Registration & Listing · Allentown, PA, US · Registration 3013764800

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
3013764800
FEI Number
3013764800
Entity Name
B. BRAUN MEDICAL INC.
City/State/Country
Allentown, PA, US
Establishment Address
861 Marcon Blvd., Allentown, PA 18109, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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

B-SMART

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2008-02-22
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2020-07-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-07-10
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2015-06-25
FOX Stand, Infusion General Hospital Class 1 880.6990 1992-12-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FMF Syringe, Piston General Hospital Class 2 880.5860 2001-07-18
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2008-02-22
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2020-09-24
FMF Syringe, Piston General Hospital Class 2 880.5860 2024-07-23
QEH Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact General Hospital Class 2 880.5860 2024-07-23
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2008-02-22
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-11-28
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-07-01
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2007-10-24
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 1992-08-27
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-09-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-11-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-21
FRN Pump, Infusion General Hospital Class 2 880.5725 2013-11-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-11-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2015-12-10
OFF Central Venous Catheter Tray Cardiovascular Class 2 870.1140 2020-08-12
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
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2011-06-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2021-07-28
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2021-07-28
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2007-09-06
BXN Stimulator, Nerve, Battery-Powered Anesthesiology Class 2 868.2775 2007-10-12
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2007-11-09
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2007-10-12
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 1992-12-09
OFL Percutaneous Sheath Introducer Kit Cardiovascular Class 2 870.1340 2017-05-04
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-03-20
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2011-06-20
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2003-07-17
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2018-07-18
FRN Pump, Infusion General Hospital Class 2 880.5725 2018-07-18
FRN Pump, Infusion General Hospital Class 2 880.5725 2013-11-15
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2013-01-29
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-11-01
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2008-11-07
KPE Container, I.V. General Hospital Class 2 880.5025 2008-02-22
MRZ Accessories, Pump, Infusion General Hospital Class 2 880.5725 2018-08-22
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-09-07
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2013-11-15
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2013-09-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-07-23
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2013-01-29
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2021-12-08
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
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2009-09-24
FRO Dressing, Wound, Drug Unknown Class U N/A 2014-12-22
FRN Pump, Infusion General Hospital Class 2 880.5725 2020-08-03
MRZ Accessories, Pump, Infusion General Hospital Class 2 880.5725 2020-08-03
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2024-09-04
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2009-09-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2001-07-18
FMJ Manometer, Spinal-Fluid General Hospital Class 2 880.2500 2008-02-22
MON System, Hemodialysis, Remote Accessories Gastroenterology, Urology Class 1 876.5820 2020-07-08
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-11-19
BXN Stimulator, Nerve, Battery-Powered Anesthesiology Class 2 868.2775 2015-07-22
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2024-09-04
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2020-07-16
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
FMF Syringe, Piston General Hospital Class 2 880.5860 2013-11-15
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2025-03-26
OUG Medical Device Data System General Hospital Class 1 880.6310 2015-02-20
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2020-11-23
NEP System/Device, Pharmacy Compounding General Hospital Class 2 880.5440 2016-06-07
FRN Pump, Infusion General Hospital Class 2 880.5725 2014-11-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 1992-08-27
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2001-07-18
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2008-02-22
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 2021-11-19
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2016-05-05
FRN Pump, Infusion General Hospital Class 2 880.5725 2021-07-01
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-10-11
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2001-07-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2001-07-18
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-05-31
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-09-23
FRN Pump, Infusion General Hospital Class 2 880.5725 2009-09-23
FRO Dressing, Wound, Drug Unknown Class U N/A 2017-08-29
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
BXN Stimulator, Nerve, Battery-Powered Anesthesiology Class 2 868.2775 2013-11-15
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2021-12-13
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2010-08-05
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2016-01-15
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2022-07-29
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2008-02-22
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2015-10-19
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2015-03-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-28
OXQ Dressing Change Tray General Hospital Class 1 880.5075 2015-03-09
FRO Dressing, Wound, Drug Unknown Class U N/A 2012-12-18
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2001-07-18
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2010-12-18
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2001-07-18
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2025-08-25
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2013-01-29
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2019-01-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-02-22
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2001-07-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2011-12-02
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2020-08-19
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-11-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-08-28
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2017-08-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-08-11
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2018-01-03
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2013-01-29
OFU Spinal Anesthesia Kit Anesthesiology Class 2 868.5120 2012-03-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2015-06-11
ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System General Hospital Class 2 880.5440 2023-12-10
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2007-11-09
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2022-02-23
OGA Brachial Plexus Anesthesia Kit Anesthesiology Class 2 868.5140 2012-03-28
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2013-01-29
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2013-01-29
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FRN Pump, Infusion General Hospital Class 2 880.5725 2015-12-10
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2001-07-18

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
2523676 B. BRAUN US DEVICE MANUFACTURING LLC ALLENTOWN, PA, US

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K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013764800. Last updated year: 2026. Please use registration number 3013764800 when referencing this establishment in official correspondence.
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