Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024999438

FEI Number

3024999438

Entity Name

OUACHITA CONTRACT MANUFACTURING, LLC

City/State/Country

Monroe, LA, US

Establishment Address

2801 Sterlington Road, Monroe, LA 71203, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Ouachita Contract Manufacturing, LLC (Owner Number: 10086452)

Owner / Operator Contact Address

2801 Sterlington Road, Monroe, LA 71203, US

Initial Importer Flag

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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-12-12
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-12-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-12-12
FNN	Nipple, Lambs Feeding	General Hospital	Class 1	880.5640	2022-12-12
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-12-12
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2022-12-12
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2022-12-12
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2022-12-12
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2022-12-12
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2022-12-12
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2022-12-12

Official Correspondent

Joseph Hakim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ouachita Contract Manufacturing, LLC

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
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
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024999438. Last updated year: 2026. Please use registration number 3024999438 when referencing this establishment in official correspondence.