Data / Medical devices / United States / Ouachita Contract Manufacturing, LLC

Ouachita Contract Manufacturing, LLC: FDA-registered device maker in Monroe, LA, United States, 3 510(k) clearances

Name: Ouachita Contract Manufacturing, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ouachita Contract Manufacturing, LLC is registered with the FDA (registration 3024999438) in Monroe, LA, United States. It lists 12 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 28, 2018. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3024999438
Address: 2801 Sterlington Road, Monroe, LA, United States, 71203
Owner or operator: Ouachita Contract Manufacturing, LLC (10086452)
Roles: Repackager or relabeler, Specification developer
First device listed: December 12, 2022
Registered through: 2026
Brand names listed: DR Talbot's

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Nipple, Lambs Feeding	FNN	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Pump, Nebulizer, Electrically Powered	JPW	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Ring, Teething, Non-Fluid Filled	MEF	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Repackager or relabeler, Specification developer	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
November 28, 2018	K180207	Non-contact Infrared Thermometer	FLL	Substantially Equivalent	Alicn Medical (Shenzhen), Inc.	accessdata.fda.gov
November 12, 2013	K132085	ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM	LCX	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
November 21, 2002	K023711	DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE	FLL	Substantially Equivalent	Acute Ideas Co. , Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 28, 2018. 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.