B. BRAUN MEDICAL INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 5 510(k) filings: 0 Recalls: 3

Known Identifiers & Locations

FEI Numbers 1641965, 2021236, 2521402, 2523676, 3003218564, 3003767881, 3013764800
Owner Operator Numbers 9925035
Locations Covered ALLENTOWN, PA, US; Allentown, PA, US; BETHLEHEM, PA, US; IRVINE, CA, US; SANTO DOMINGO Distrito Nacional, DO

Registered Establishments (5)

Registration # Establishment Name Location Establishment Type(s) Action
2021236 B. BRAUN US PHARMACEUTICAL MANUFACTURING LLC IRVINE, CA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
2521402 B. BRAUN MEDICAL INC. BETHLEHEM, PA, US Develop Specifications But Do Not Manufacture At This Facility View Details
2523676 B. BRAUN US DEVICE MANUFACTURING LLC ALLENTOWN, PA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3013764800 B. BRAUN MEDICAL INC. Allentown, PA, US Complaint File Establishment per 21 CFR 820.198 View Details
9614279 B. BRAUN DOMINICAN REPUBLIC INC. SANTO DOMINGO Distrito Nacional, DO Manufacture Medical Device for Another Party (Contract Manufacturer) View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (3)

Recall # Product Description Initiation Date Status Action
Z-0003-06 D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. Reason: package sealing defect - product may not be sterile 2005-09-15 Terminated View Details
Z-0007-2012 Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required. Reason: The Outlook ES Dose Guard Care Area can inadvertently be exited when the pump enters the KVO (Keep Vein Open) state. The same condition can occur when a sequence of HOLD-HOLD key strokes are performed on the pump key panel. 2010-07-20 Terminated View Details
Z-0009-2023 Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access. Reason: Potential for leakage at the catheter hub. 2022-09-01 Open, Classified View Details

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