B. BRAUN DOMINICAN REPUBLIC INC.

FDA Device Registration & Listing · SANTO DOMINGO Distrito Nacional, DO · Registration 9614279

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614279
FEI Number
3003767881
Entity Name
B. BRAUN DOMINICAN REPUBLIC INC.
City/State/Country
SANTO DOMINGO Distrito Nacional, DO
Establishment Address
KM. 22, LAS AMERICAS HWY, PARQUE LAS AMERICAS, SANTO DOMINGO Distrito Nacional --, DO
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
B. BRAUN MEDICAL INC. (Owner Number: 9925035)
Owner / Operator Contact Address
824 Twelfth Avenue, --, Bethlehem, PA 18018, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2016-04-07
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-05-15
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2010-08-05
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2007-09-06
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 1993-12-29
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 1999-06-04
FMF Syringe, Piston General Hospital Class 2 880.5860 2001-07-18
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2025-03-26
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 1992-08-27
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 1992-08-27
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2008-11-14
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-11-01
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2024-06-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-09-06
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2013-12-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-28
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-08-21
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2008-11-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2001-07-18
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2003-07-17
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2011-06-20
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2013-06-21
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2013-01-29
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-03-02
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
FRN Pump, Infusion General Hospital Class 2 880.5725 2014-11-07
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2001-07-18
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-11-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-12-10
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-04-10
FMF Syringe, Piston General Hospital Class 2 880.5860 2011-06-29
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2017-11-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-12-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-10-23
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 1999-06-04
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-09
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2008-02-22
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2011-06-20
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2008-02-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
LCJ Tissue Expander And Accessories Unknown Class U N/A 2007-10-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2007-11-09
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2001-07-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-02-22
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2009-09-23
FRN Pump, Infusion General Hospital Class 2 880.5725 2009-09-23

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: B. BRAUN MEDICAL, INC. Email: kamaal.anas@bbraunusa.com Phone: (484) 5231349

Related Public Records

Same Entity

B. BRAUN MEDICAL INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2021236 B. BRAUN US PHARMACEUTICAL MANUFACTURING LLC IRVINE, CA, US
2521402 B. BRAUN MEDICAL INC. BETHLEHEM, PA, US
3013764800 B. BRAUN MEDICAL INC. Allentown, PA, US
2523676 B. BRAUN US DEVICE MANUFACTURING LLC ALLENTOWN, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614279. Last updated year: 2026. Please use registration number 9614279 when referencing this establishment in official correspondence.
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