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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-11-09 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2008-02-22 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2020-07-10 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-07-10 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2015-06-25 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1992-12-09 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2008-02-22 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2001-07-18 |
| Spinal Epidural Anesthesia Kit | OFT | Class 2 | Anesthesiology | No | 2012-03-28 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2020-09-24 |
| Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | QEH | Class 2 | General Hospital | No | 2024-07-23 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2008-02-22 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2012-03-28 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2021-07-01 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2007-10-24 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-09-30 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2015-12-10 |
| Central Venous Catheter Tray | OFF | Class 2 | Cardiovascular | No | 2020-08-12 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2011-06-20 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | Class 2 | General Hospital | No | 2021-07-28 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2007-09-06 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2007-10-12 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2007-11-09 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2007-10-12 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 1992-12-09 |
| Percutaneous Sheath Introducer Kit | OFL | Class 2 | Cardiovascular | No | 2017-05-04 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2003-07-17 |
| Pump, Infusion, Enteral | LZH | Class 2 | General Hospital | No | 2018-07-18 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2013-01-29 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2008-11-07 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2008-02-22 |
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2018-08-22 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2018-09-07 |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | Class 2 | Gastroenterology, Urology | No | 2013-01-29 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2022-05-18 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2014-12-22 |
| Filter, Intravascular, Cardiovascular | DTK | Class 2 | Cardiovascular | No | 2024-09-04 |
| Manometer, Spinal-Fluid | FMJ | Class 2 | General Hospital | No | 2008-02-22 |
| System, Hemodialysis, Remote Accessories | MON | Class 1 | Gastroenterology, Urology | No | 2020-07-08 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2015-02-20 |
| System/Device, Pharmacy Compounding | NEP | Class 2 | General Hospital | No | 2016-06-07 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2007-10-11 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2010-08-05 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2015-10-19 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2015-03-09 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2010-12-18 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2008-02-22 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2020-08-19 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2001-07-18 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2013-01-29 |
| Spinal Anesthesia Kit | OFU | Class 2 | Anesthesiology | No | 2012-03-28 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2015-06-11 |
| Brachial Plexus Anesthesia Kit | OGA | Class 2 | Anesthesiology | No | 2012-03-28 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2001-07-18 |
| Pump, Infusion, Pca | MEA | Class 2 | General Hospital | No | 2013-11-15 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2015-02-20 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2014-01-07 |
| System, Dialysate Delivery, Central Multiple Patient | FKQ | Class 2 | Gastroenterology, Urology | No | 2013-01-29 |
| Nerve Block Tray | OGJ | Class 2 | Anesthesiology | No | 2012-03-28 |
| Tissue Expander And Accessories | LCJ | Class U | Unknown | No | 2007-10-12 |
| Non-Coring (Huber) Needle | PTI | Class 2 | General Hospital | No | 2017-11-29 |
| Pump, Infusion, Elastomeric | MEB | Class 2 | General Hospital | No | 2012-11-27 |
Proprietary Names
B-SMART
Establishment Types
Complaint File Establishment per 21 CFR 820.198