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Data / Medical devices / United States / Medique Products

Medique Products: FDA-registered device maker in Fort Myers, FL, United States, 2 510(k) clearances

Medique Products is registered with the FDA (registration 1420763) in Fort Myers, FL, United States. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 12, 2008. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
1420763
FEI number
1833338
Address
17080 Alico Commerce CT Ste 1, Fort Myers, FL, United States, 33967
Owner or operator
UniFirst First Aid Corporation (9005674)
Roles
Manufacturer, Repackager or relabeler
First device listed
September 14, 1992
Registered through
2026
Brand names listed
Adhesive Bandage, Non-woven, 4, BMD Adhesive Bandage, 35, BMD Adhesive Bandage, Fingertip, Regular, Cederroth 4 in one Blood Stopper, Cederroth 4 in one Mini Blood Stopper, Cederroth First Aid Cabinet, Cederroth First Aid Station, Cederroth Soft Foam Bandage BI and more

Devices it lists

DeviceProduct codeClassRoleSource
Bandage, ElasticFQM1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Burn Kit With DrugOJINRepackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNManufacturer, Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Pad, EyeHMP1Repackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Repackager or relabeleraccessdata.fda.gov
Vapocoolant DeviceMLYURepackager 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
September 12, 2008K081569DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGSLZASubstantially EquivalentDynarex Corporationaccessdata.fda.gov
June 10, 2005K033720ARI COLD SPRAYMLYSubstantially EquivalentAriaccessdata.fda.gov

Compare with other makers

Updated September 12, 2008. 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.