Contract manufacturerContract sterilizerB. BRAUN US DEVICE MANUFACTURING LLC (Allentown, PA)PennsylvaniaAnesthesiologyCardiovascularGastroenterology and urologyGeneral hospitalPathologyGeneral and plastic surgeryOrthopedicRadiologyOphthalmicClass IIClass IUnclassifiedClass III
B. BRAUN US DEVICE MANUFACTURING LLC
Contract manufacturer and sterilizer · Allentown, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2523676 (openFDA record; or search FDA's registration database)
- FEI number
- 2523676
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Repackager or relabeler; Contract sterilizer
- Owner or operator
- B. BRAUN MEDICAL INC. (FDA owner/operator no. 9925035)
- Registered address
- 901 Marcon Blvd, Allentown, PA 18109
- Contract listings
- 89 device listings, 51 product codes, first listed Aug 27, 1992
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| BSO | Catheter, Conduction, Anesthetic | Class II | Anesthesiology | Contract manufacturing | Dec 18, 2010 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Class II | Anesthesiology | Contract manufacturing | Jul 18, 2001 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Class II | Anesthesiology | Contract sterilization | Nov 15, 2007 |
| CAZ | Anesthesia Conduction Kit | Class II | Anesthesiology | Contract manufacturing | Jul 18, 2001 |
| CAZ | Anesthesia Conduction Kit | Class II | Anesthesiology | Contract sterilization | Nov 15, 2007 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class I | Anesthesiology | Contract manufacturing | Aug 15, 2014 |
| DQO | Catheter, Intravascular, Diagnostic | Class II | Cardiovascular | Contract manufacturing | Oct 11, 2007 |
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | Contract manufacturing | Feb 22, 2008 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | Contract manufacturing | Jul 18, 2001 |
| DWQ | Stripper, Vein, External | Class II | Cardiovascular | Contract manufacturing | May 2, 2008 |
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract manufacturing | Feb 22, 2008 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract manufacturing | Nov 9, 2007 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | Contract sterilization | May 18, 2022 |
| DYG | Catheter, Flow Directed | Class II | Cardiovascular | Contract manufacturing | Nov 9, 2007 |
| EYI | Adaptor, Ureteral Catheter | Class I | Gastroenterology and urology | Contract manufacturing | May 2, 2014 |
| FMF | Syringe, Piston | Class II | General hospital | Contract manufacturing | Jul 18, 2001 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract manufacturing | Jan 3, 2020 |
| FMI | Needle, Hypodermic, Single Lumen | Class II | General hospital | Contract manufacturing | Jul 18, 2001 |
| FMJ | Manometer, Spinal-Fluid | Class II | General hospital | Contract manufacturing | Feb 22, 2008 |
| FOX | Stand, Infusion | Class I | General hospital | Contract manufacturing | Dec 9, 1992 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class II | General hospital | Contract manufacturing | May 18, 2022 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class II | General hospital | Contract sterilization | May 18, 2022 |
| FPA | Set, Administration, Intravascular | Class II | General hospital | Contract manufacturing | Aug 27, 1992 |
| FRN | Pump, Infusion | Class II | General hospital | Contract manufacturing | Nov 2, 2010 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract manufacturing | Jul 17, 2003 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | Class II | General and plastic surgery | Contract sterilization | Sep 2, 2016 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract manufacturing | Jun 21, 2013 |
| GBX | Catheter, Irrigation | Class I | General and plastic surgery | Contract manufacturing | Jul 18, 2001 |
| GCB | Needle, Catheter | Class I | General and plastic surgery | Contract manufacturing | Feb 29, 2016 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract sterilization | Sep 2, 2016 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Dec 13, 2012 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Dec 14, 2012 |
| IWJ | System, Applicator, Radionuclide, Manual | Class I | Radiology | Contract manufacturing | May 30, 2025 |
| IZI | System, X-Ray, Angiographic | Class II | Radiology | Contract manufacturing | Oct 12, 2007 |
| JCY | Catheter, Infusion | Class I | General and plastic surgery | Contract manufacturing | Oct 24, 2007 |
| KDQ | Bottle, Collection, Vacuum | Class II | General hospital | Contract manufacturing | Apr 9, 2013 |
| KGZ | Accessories, Catheter | Class I | General and plastic surgery | Contract manufacturing | Nov 7, 2008 |
| KGZ | Accessories, Catheter | Class I | General and plastic surgery | Contract sterilization | Nov 14, 2008 |
| KYG | Device, Irrigation, Ocular Surgery | Class I | Ophthalmic | Contract manufacturing | Feb 4, 2008 |
| KYX | Dispenser, Liquid Medication | Class I | General hospital | Contract manufacturing | Jul 18, 2001 |
| LCJ | Tissue Expander And Accessories | Unclassified | General and plastic surgery | Contract sterilization | Oct 12, 2007 |
| LHI | Set, I.V. Fluid Transfer | Class II | General hospital | Contract manufacturing | Jun 4, 1999 |
| LJH | System, Irrigation, Urological | Class II | Gastroenterology and urology | Contract manufacturing | Sep 14, 2026 |
| LKK | Pump, Infusion, Implanted, Programmable | Class III | General hospital | Contract manufacturing | Jan 18, 2013 |
| LRS | I.V. Start Kit | Class II | General hospital | Contract manufacturing | Jan 7, 2014 |
| LYV | Label Or Tag, Sterile | Class I | General and plastic surgery | Contract manufacturing | Jun 25, 2015 |
| NEP | System/Device, Pharmacy Compounding | Class II | General hospital | Contract manufacturing | Feb 24, 2016 |
| OFL | Percutaneous Sheath Introducer Kit | Class II | Cardiovascular | Contract manufacturing | May 4, 2017 |
| OFT | Spinal Epidural Anesthesia Kit | Class II | Anesthesiology | Contract manufacturing | Mar 28, 2012 |
| OFU | Spinal Anesthesia Kit | Class II | Anesthesiology | Contract manufacturing | Mar 28, 2012 |
| OGA | Brachial Plexus Anesthesia Kit | Class II | Anesthesiology | Contract manufacturing | Mar 28, 2012 |
| OGE | Epidural Anesthesia Kit | Class II | Anesthesiology | Contract manufacturing | Mar 28, 2012 |
| OGJ | Nerve Block Tray | Class II | Anesthesiology | Contract manufacturing | Mar 28, 2012 |
| OWL | Peripheral Catheter Insertion Kit | Class II | General hospital | Contract manufacturing | Jun 11, 2015 |
| OXQ | Dressing Change Tray | Class I | General hospital | Contract manufacturing | Mar 9, 2015 |
| QPB | System, Suction, Lipoplasty For Removal | Class II | General and plastic surgery | Contract manufacturing | Jan 23, 2015 |