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Data / Medical devices / United States / Menasha Packaging Company,LLC

Menasha Packaging Company,LLC: FDA-registered device maker in Edison, NJ, United States, 14 510(k) clearances

Menasha Packaging Company,LLC is registered with the FDA (registration 3003896222) in Edison, NJ, United States. It lists 16 device types. The FDA files 14 510(k) clearances under its listings, the newest dated February 28, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3003896222
FEI number
3010687142
Address
112 Truman Dr, Edison, NJ, United States, 08817
Owner or operator
Menasha Packaging Co. LLC (10045291)
Roles
Repackager or relabeler
First device listed
November 4, 2013
Registered through
2026
Brand names listed
BNT100. BNT100US, VNT200, VNT200US, Durex Air, Durex Intense, Durex Real Feel, First Aid Kit, First aid kit with drug, Floss, Dental, HEB - Tampon, menstrual, unscented and more

Devices it lists

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
February 28, 2025K241617Durex Polyisoprene CondomMOLSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
August 23, 2024K240896ONE Nitrile CondomMOLSubstantially EquivalentGlobal Protection Corp.accessdata.fda.gov
October 12, 2022K222068Durex Penck III RegularHISSubstantially EquivalentRb Health (Us), LLCaccessdata.fda.gov
April 28, 2020K193213Vicks VNT200 No Touch Forehead ThermometerFLLSubstantially EquivalentKaz USA, Inc., A Helen of Troy Companyaccessdata.fda.gov
March 3, 2017K162746Ontex and other proprietary namesHEBSubstantially EquivalentOntex Bvbaaccessdata.fda.gov
January 29, 2015K143155LISTERINE Sensitivity Defense MouthrinseLBHSubstantially EquivalentJohnson & Johnson Healthcare Products, Division of Mcneil-Ppaccessdata.fda.gov
October 9, 2013K132819PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONSHILSubstantially EquivalentPlaytex Manufacturing, Inc.accessdata.fda.gov
January 4, 2013K123731BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAYLFDSubstantially EquivalentGlaxosmithkline Consumer Healthcare (Gskch)accessdata.fda.gov
December 23, 2009K090819ONTEX TAMPON (UNSCENTED)HEBSubstantially EquivalentOntex International NVaccessdata.fda.gov
January 17, 2008K073662PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONSHILSubstantially EquivalentPlaytex Products, Inc.accessdata.fda.gov
October 12, 2007K063295ACON UTI URINARY TRACT INFECTION TEST STRIPSLJXSubstantially EquivalentACON Laboratories, Inc.accessdata.fda.gov
June 12, 2002K020827K-Y BRAND ULTRA GEL PERSONAL LUBRICANTNUCSubstantially EquivalentPersonal Products Co., Div. of Mcneil Ppc, Inc.accessdata.fda.gov
November 9, 1998K983478ORGANIC ESSENTIALS, ORGANIC COTTON TAMPONHEBSubstantially EquivalentOrganic Essentialsaccessdata.fda.gov
January 17, 1984K834302STAYFREE* DEODORANT MAXI-PADSHHLSubstantially EquivalentJohnson & Johnson Professionals, Inc.accessdata.fda.gov

Compare with other makers

Updated February 28, 2025. 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.