Data / Medical devices / Dominican Republic / B. Braun Dominican Republic Inc.

B. Braun Dominican Republic Inc.: FDA-registered device maker in SANTO DOMINGO Distrito Nacional, Dominican Republic, 8 510(k) clearances

Name: B. Braun Dominican Republic Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

B. Braun Dominican Republic Inc. is registered with the FDA (registration 9614279) in SANTO DOMINGO Distrito Nacional, Dominican Republic. It lists 24 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 15, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9614279
FEI number: 3003767881
Address: KM. 22, Las Americas Hwy Parque Las Americas, SANTO DOMINGO Distrito Nacional, Dominican Republic, --
Owner or operator: B. BRAUN MEDICAL INC. (9925035)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: August 27, 1992
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Contract manufacturer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Contract manufacturer	accessdata.fda.gov
Catheter, Coude	EZC	2	Contract manufacturer	accessdata.fda.gov
Catheter, Infusion	JCY	1	Contract manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Contract manufacturer	accessdata.fda.gov
Device, Irrigation, Ocular Surgery	KYG	1	Contract manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Contract manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Contract manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Contract manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Contract manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Contract manufacturer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Contract manufacturer	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Contract manufacturer	accessdata.fda.gov
Tissue Expander And Accessories	LCJ	U	Contract manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Contract manufacturer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Contract manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 15, 2022	K211204	SafePort(TM) Manifold (or Stopcock)	FMG	Substantially Equivalent	Elcam Medical Acal	accessdata.fda.gov
June 10, 2011	K103736	DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE	FMF	Substantially Equivalent	Dmc Medical, Ltd.	accessdata.fda.gov
June 9, 2011	K111016	SAFEPORT MANIFOLD (TM) (OR STOPCOCK)	FPA	Substantially Equivalent	Elcam Medical Acal	accessdata.fda.gov
April 13, 2006	K060231	CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK	FMG	Substantially Equivalent	Elcam Medical Acal	accessdata.fda.gov
September 12, 2003	K032393	INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)	FMG	Substantially Equivalent	Elcam Medical Acal	accessdata.fda.gov
October 18, 2002	K022895	ELCAM STOPCOCKS AND MANIFOLDS	FMG	Substantially Equivalent	Medical Device Consultants, Inc.	accessdata.fda.gov
March 27, 2002	K013949	UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR	FPA	Substantially Equivalent	Churchill Medical Systems, Inc.	accessdata.fda.gov
November 30, 1989	K894446	ANGEION HEMOSTASIS VALVE INTRODUCER	DYB	Substantially Equivalent	Angeion Corp.	accessdata.fda.gov

Compare with other makers

Updated September 15, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.