Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003965134

FEI Number

3003965134

Entity Name

RECE INTERNATIONAL CORP.

City/State/Country

Miami Lakes, FL, US

Establishment Address

15260 NW 60th Ave, Miami Lakes, FL 33014, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

RECE INTERNATIONAL CORP. (Owner Number: 9071876)

Owner / Operator Contact Address

15260 NW 60 AVE., --, Miami Lakes, FL 33014, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VIAMED NON-POWERED BREAST PUMP VIAMED BALLOON TYPE CATHETER VIAMED MICROSCOPE SLIDE VIAMED MEDICAL ADHESIVE VIAMED SURGICAL DRESS VIAMED NON-VENTILATORY NEBULIZER VIAMED VAGINAL DOUCHE Viamed Conductive Shoe and Shoe Cov VIAMED STERILE UROSHEA VIAMED INFUSION CATHETER COLD WATER BOTTLE VIAMED HOT VIAMED NONPNEUMATIC TOURNIQUET VIAMED INJECTION CANNULA VIAMED STERILE SPECIMEN CONTAINER Viamed Tweezer Adhesive Ostomy Pouch and Access VIAMED SCALPEL VIAMED URINAL ViaMed Enteral Feeding Gravity Set Bag Connector Enfit VIAMED EMESIS BASIN Well Care (Wuhan) Medical Technology Co. Ltd. ViaMed Sterile Silicone Round Wound Drains Rece International Corp VIAMED OPERATING ROOM SHOES VIAMED NASAL OXYGEN CANNULA VIAMED WOUND DRESSING VIAMED CONTINUOUS VIAMED UMBILICAL SCISSORS VIAMED NON-SURGICA VIAMED COLOSTOMY BAG Viamed VIAMED STERILE LEG VIAMED TONSIL SUCTION TUBE VIAMED STERILE CORR VIAMED SURGICAL CAP VIAMED CLINICAL MERCURY THERMOMETER VIAMED OXYGEN MASK Viamed Hypodermic Single Lumen Needle Viamed Surgical Drape VIAMED TISSUE CULTURE DISH VIAMED SURGICAL INSTR ViaMed Endotracheal Tube Holder VIAMED WOUND AND BURN DRESSING VIAMED ALCOHOL PREP PADS ALCOHOL SWABS STICKS Viamed Urine Collectring Bag VIAMED NONMETAL VAGINAL SPECULUM VIAMED TRACHEAL TUBE CLEANING BRUSH VIAMED FINGER SPLINT VIAMED NON-STERILE VIAMED WOUND DRESSING Viamed Manual Surgical Instruments Viamed Cytology Kit VIAMED OPERATING ROOM SHOE COVER SPONGE VIAMED NONRESORBABLE GAUZE VIAMED NON-STERILE UROSH Viamed General Surgery Biopsy Brush VIAMED MULTIPLE LUMEN CATHETER ViaMed Cotton Roll VIAMED NON-STERILE NO VIAMED INTERNAL X-RAY DETECT GAUZE SPONGE VIAMED PROTECTIVE APRON VIAMED WOUND DRESSING VIAMED BEDPAN VIAMED ICE BAG VIAMED VENTRICULAR CATHETER VIAMED VENTILATOR AND TUBING SET VIAMED GASTROENTERO VIAMED RECTAL ILEOSTOMY CATHETER ES VIAMED INTRODUCTION/DRAINAGE CATHET VIAMED OVER THE COU VIAMED TRACHEOBRONCH VIAMED NON-STERILE CO Viamed Ent Applicator Well Care (Wuhan) Medical Technology Co. Ltd. VIAMED TRACHEAL TUBE VIAMED TISSUE CULTURE EQUIPMENT VIAMED EAR EXCAVATOR Viamed Orthopedic Padding VIAMED ELASTIC BANDAGE Viamed Non Surgical Isolation Gown Viamed Centrifuge Lab Equipment VIAMED OXYGEN MASK VIAMED OXIMETER VIAMED MANUAL STETHOSCOPE VIAMED STERILE ABSORB

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2006-03-30
GBA	Catheter, Balloon Type	General, Plastic Surgery	Class 1	878.4200	2006-04-14
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2006-02-23
MZR	Topical Approximation System	General Hospital	Class 1	880.5240	2006-04-14
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2006-02-23
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2007-12-13
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2006-02-23
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2009-11-13
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-02-23
JCY	Catheter, Infusion	General, Plastic Surgery	Class 1	878.4200	2006-02-23
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2006-02-23
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2008-09-20
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2006-02-23
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2007-04-24
KCX	Epilator, High Frequency, Tweezer-Type	General, Plastic Surgery	Class 1	878.5360	2011-06-11
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2009-09-18
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2006-03-30
FNP	Urinal	General Hospital	Class 1	880.6730	2008-09-18
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2026-03-16
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2008-09-18
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2024-07-11
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2025-01-02
FXW	Shoes, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2006-02-23
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2007-12-09
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2007-12-13
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2006-02-23
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2006-02-23
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2006-02-23
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2007-12-13
BYZ	Trap, Sterile Specimen	General Hospital	Class 2	880.6740	2010-01-25
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-02-23
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2006-04-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-07-31
EYT	Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-04-14
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2006-02-23
FLK	Thermometer, Clinical Mercury	General Hospital	Class 2	880.2920	2006-02-23
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-12-13
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2010-01-25
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2022-12-28
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2006-02-23
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2006-03-30
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2025-05-12
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2007-12-13
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2007-04-24
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2014-03-11
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2006-03-30
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2006-03-30
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2025-01-02
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2007-04-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2007-12-13
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2010-10-05
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	Class 2	884.4530	2010-12-10
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2006-02-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2006-02-23
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-02-23
GEE	Brush, Biopsy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-10-05
GBP	Catheter, Multiple Lumen	General, Plastic Surgery	Class 1	878.4200	2006-03-30
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-07-31
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2024-07-31
EFN	Cotton, Roll	Dental	Class 1	872.6050	2008-09-18
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-02-23
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2006-02-23
IWO	Apron, Protective	Radiology	Class 1	892.6500	2006-02-23
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2007-12-13
FOB	Bedpan	General Hospital	Class 1	880.6730	2008-09-18
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2006-02-23
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2006-02-23
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2007-12-09
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2007-04-24
KPH	Catheter, Rectal For Continent Ileostomy	Gastroenterology, Urology	Class 1	876.5030	2006-02-23
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2006-02-23
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	Class 1	864.3260	2006-02-23
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2006-04-14
NNY	Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-04-14
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2010-10-05
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2024-07-11
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2008-09-18
KJG	Tube, Tissue Culture	Pathology	Class 1	864.3010	2007-04-24
JYH	Excavator, Ear	Ear, Nose, Throat	Class 1	874.4420	2006-02-23
ITG	Bandage, Cast	Physical Medicine	Class 1	890.3025	2014-03-11
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-04-14
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2009-09-23
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2010-03-04
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2007-12-13
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-05-20
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2006-02-23
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2006-02-23

Official Correspondent

Ana Carrasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RECE INTERNATIONAL CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K772144	Medline Industries, Inc.	CATHETER, DISP., EXTERNAL, MALE	1977-11-28
K945628	Mentor Corp.	CLEAR ADVANTAGE II	1995-07-06
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003965134. Last updated year: 2026. Please use registration number 3003965134 when referencing this establishment in official correspondence.