FDA Registration
Active
🇺🇸 United States
B. BRAUN US DEVICE MANUFACTURING LLC
Reg #: 2523676
·
FEI: 2523676
·
Expires 2026
Products
57
Proprietary Names
0
Establishment Types
3
Classifications
57
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Registration Details
- Registration Name
- B. BRAUN US DEVICE MANUFACTURING LLC
- Registration Number
- 2523676
- FEI Number
- 2523676
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 901 Marcon Blvd
- City
- ALLENTOWN
- State
- PA
- ZIP
- 18109
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002689
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 |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2013-01-30 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2013-03-21 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1992-12-09 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2001-07-18 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2016-02-22 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2015-10-19 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2025-05-30 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-11-09 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2011-06-20 |
| System/Device, Pharmacy Compounding | NEP | Class 2 | General Hospital | No | 2016-02-24 |
| Brachial Plexus Anesthesia Kit | OGA | Class 2 | Anesthesiology | No | 2012-03-28 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2012-03-12 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2012-09-07 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2008-02-04 |
| Spinal Anesthesia Kit | OFU | Class 2 | Anesthesiology | No | 2012-03-28 |
| Catheter, Flow Directed | DYG | Class 2 | Cardiovascular | No | 2012-12-14 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2014-01-07 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2008-02-22 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-09-02 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2016-09-02 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2008-02-22 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2010-11-02 |
| Tissue Expander And Accessories | LCJ | Class U | Unknown | No | 2007-10-12 |
| Spinal Epidural Anesthesia Kit | OFT | Class 2 | Anesthesiology | No | 2012-03-28 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2013-11-15 |
| Pump, Infusion, Implanted, Programmable | LKK | Class 3 | Unknown | No | 2018-01-09 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2008-02-22 |
| Manometer, Spinal-Fluid | FMJ | Class 2 | General Hospital | No | 2008-02-22 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2012-12-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2012-12-13 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2012-03-28 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2001-07-18 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2001-07-18 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2020-08-19 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2013-04-09 |
| Adaptor, Ureteral Catheter | EYI | Class 1 | Gastroenterology, Urology | No | 2014-05-02 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2020-01-03 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2001-07-18 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2007-10-11 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2015-01-23 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2007-10-12 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2014-08-15 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2022-05-18 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2001-07-18 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2013-12-05 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2003-07-17 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2007-10-24 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2010-08-05 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2013-06-21 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2001-07-18 |
| Percutaneous Sheath Introducer Kit | OFL | Class 2 | Cardiovascular | No | 2017-05-04 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2007-09-06 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2015-06-25 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2015-03-09 |
| Nerve Block Tray | OGJ | Class 2 | Anesthesiology | No | 2012-03-28 |
| Stripper, Vein, External | DWQ | Class 2 | Cardiovascular | No | 2008-05-02 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2015-06-11 |
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)