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Data / Medical devices / United States / We Pack Logistics, LLC

We Pack Logistics, LLC: FDA-registered device maker in Paris, TX, United States, 5 510(k) clearances

We Pack Logistics, LLC is registered with the FDA (registration 1651897) in Paris, TX, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 20, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1651897
FEI number
3004334060
Address
2300 13th St Sw, Paris, TX, United States, 75460
Owner or operator
WE PACK LOGISTICS, LP (9045125)
Roles
Repackager or relabeler
First device listed
March 15, 2001
Registered through
2026
Brand names listed
Huggies, Depends, Kroger

Devices it lists

DeviceProduct codeClassRoleSource
Garment, Protective, For IncontinenceEYQ1Repackager or relabeleraccessdata.fda.gov
Pad, Menstrual, UnscentedHHD1Repackager or relabeleraccessdata.fda.gov
Tampon, Menstrual, UnscentedHEB2Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 20, 2019K191666Unscented W long plastic and cardboard applicator tamponsHEBSubstantially EquivalentOntex Bvbaaccessdata.fda.gov
March 3, 2017K162746Ontex and other proprietary namesHEBSubstantially EquivalentOntex Bvbaaccessdata.fda.gov
April 23, 2014K132595ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONSHEBSubstantially EquivalentOntex Bvbaaccessdata.fda.gov
October 7, 2011K112635U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONSHEBSubstantially EquivalentKimberly-Clark Corp.accessdata.fda.gov
December 23, 2009K091749U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUSHEBSubstantially EquivalentKimberly-Clark Corp.accessdata.fda.gov

Compare with other makers

Updated December 20, 2019. 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.