Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009265194

FEI Number

3009265194

Entity Name

Remington Medical, S.A.

City/State/Country

Santo Domingo Este, DO

Establishment Address

Zona Franca Industrial de las Americas, Edificio B-11, Km. 22 Autopista Las Americas, Santo Domingo Este 15001, DO

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

REMINGTON MEDICAL, INC. (Owner Number: 9006473)

Owner / Operator Contact Address

6830 MEADOWRIDGE CT., --, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VascuChek Surgical Probe VascuChek Transceiver VascuChek Clinical Probe VascuChek Charger VascuChek Kit VascuChek System Bionix Internal Feeding Tube Declogger McKesson Internal Feeding Tube Declogger VascuChek Aspiration and Injection Needles Remington Medical Chiba Needle Marked TendoNova Ocelot TDS 1000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2022-02-01
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2018-09-27
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	Class 2	886.5200	2021-05-26
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2019-09-17
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2021-10-12
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-12-13
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2025-11-21
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2007-11-09
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2015-10-07
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-11-09
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2006-02-28
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2022-09-29
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-03-11
DTA	Tester, Pacemaker Electrode Function	Cardiovascular	Class 2	870.3720	2013-03-11

Official Correspondent

No official correspondent registered.

US Agent Details

Attly Aycock Business: REMINGTON MEDICAL, INC. Email: AttlyA@remmed.com Phone: (770) 8888520

Related Public Records

Same Entity

REMINGTON 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
3007014520	Remington Medical, Inc.	Alpharetta, GA, US
1056553	REMINGTON MEDICAL, INC.	ALPHARETTA, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903633	Transonic Systems, Inc.	ADVANCE LASER FLOWMETER, ALF 21	1990-10-09
K182494	Laser Associated Sciences, Inc.	FlowMet-R	2019-02-27
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009265194. Last updated year: 2026. Please use registration number 3009265194 when referencing this establishment in official correspondence.