FDA Registration Active 🇺🇸 United States

B. BRAUN MEDICAL INC.

Reg #: 3013764800 · FEI: 3013764800 · Expires 2026
Products
62
Proprietary Names
1
Establishment Types
1
Classifications
62

Registration Details

Registration Name
B. BRAUN MEDICAL INC.
Registration Number
3013764800
FEI Number
3013764800
Status
Active
Expiry Year
2026
Initial Importer
No
Address
861 Marcon Blvd.
City
Allentown
State
PA
ZIP
18109
Country
US

Regulatory Submissions

510(k) Number
K915421

Owner / Operator

Firm Name
B. BRAUN MEDICAL INC.
Operator Number
9925035
Address
824 Twelfth Avenue, --
City
Bethlehem
State
PA
Postal Code
18018
Country
US
Correspondent
Kamaal Anas

Products

Device Name Product Code
Introducer, Catheter DYB
Injector And Syringe, Angiographic DXT
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
System, Imaging, Pulsed Echo, Ultrasonic IYO
Label Or Tag, Sterile LYV
Stand, Infusion FOX
Set, Administration, Intravascular FPA
Syringe, Piston FMF
Spinal Epidural Anesthesia Kit OFT
Anesthesia Conduction Kit CAZ
Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact QEH
Set, I.V. Fluid Transfer LHI
Epidural Anesthesia Kit OGE
Pump, Infusion FRN
Catheter, Infusion JCY
Transducer, Ultrasonic, Diagnostic ITX
Subsystem, Water Purification FIP
Central Venous Catheter Tray OFF
Stopcock, I.V. Set FMG
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
System, Irrigation, Urological LJH
Stimulator, Nerve, Battery-Powered BXN
Catheter, Flow Directed DYG
System, X-Ray, Angiographic IZI
Dispenser, Liquid Medication KYX
Percutaneous Sheath Introducer Kit OFL
Needle, Aspiration And Injection, Disposable GAA
Pump, Infusion, Enteral LZH
Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
Accessories, Catheter KGZ
Container, I.V. KPE
Accessories, Pump, Infusion MRZ
Needle, Hypodermic, Single Lumen FMI
Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
Dressing, Wound, Drug FRO
Filter, Intravascular, Cardiovascular DTK
Manometer, Spinal-Fluid FMJ
System, Hemodialysis, Remote Accessories MON
Medical Device Data System OUG
System/Device, Pharmacy Compounding NEP
Catheter, Intravascular, Diagnostic DQO
Device, Intravascular Catheter Securement KMK
Catheter, Irrigation GBX
Dressing Change Tray OXQ
Catheter, Conduction, Anesthetic BSO
Wire, Guide, Catheter DQX
Needle, Catheter GCB
Catheter, Percutaneous DQY
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
Spinal Anesthesia Kit OFU
Peripheral Catheter Insertion Kit OWL
Brachial Plexus Anesthesia Kit OGA
Syringe, Irrigating (Non Dental) KYZ
Pump, Infusion, Pca MEA
Disinfectant, Medical Devices LRJ
I.V. Start Kit LRS
System, Dialysate Delivery, Central Multiple Patient FKQ
Nerve Block Tray OGJ
Tissue Expander And Accessories LCJ
Non-Coring (Huber) Needle PTI
Pump, Infusion, Elastomeric MEB

Proprietary Names

B-SMART

Establishment Types

Complaint File Establishment per 21 CFR 820.198