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Data / Medical devices / United States / Redicare LLC

Redicare LLC: FDA-registered device maker in Congers, NY, United States, 2 510(k) clearances

Redicare LLC is registered with the FDA (registration 3013034812) in Congers, NY, United States. It lists 22 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 20, 2020. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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FDA registration number
3013034812
Address
225 N Route 303 Ste 101, Congers, NY, United States, 10920
Owner or operator
Redicare LLC (10053279)
Roles
Repackager or relabeler, Specification developer
First device listed
November 16, 2016
Registered through
2026
Brand names listed
Basic First Aid Kit, Blood Borne Pathogen Kit, Burn Kit, Foil Emergency Blanket, Latex-Free Disposable Emergency Tourniquet, Overdose Response Kit, RediBurn Burn Dressing, RediRescue CPR Mask Adult/Infant and more

Devices it lists

DeviceProduct codeClassRoleSource
Bandage, ElasticFQM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Body Fluid Clean Up KitOKG2Repackager or relabeler, Specification developeraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeler, Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNSpecification developeraccessdata.fda.gov
First Aid Kit Without DrugOHO1Repackager or relabeler, Specification developeraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Mask, OxygenBYG1Repackager or relabeleraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Repackager or relabeleraccessdata.fda.gov
Medical Glove, SpecialtyLZC1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBURepackager or relabeleraccessdata.fda.gov
Polymer Patient Examination GloveLZA1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, Medical, DisposableJOK1Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Repackager or relabeler, Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeler, Specification developeraccessdata.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
August 20, 2020K200093Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy DrugLZASubstantially EquivalentAnhui Lntco Medical Products Co., Ltd.accessdata.fda.gov
June 10, 2005K033720ARI COLD SPRAYMLYSubstantially EquivalentAriaccessdata.fda.gov

Compare with other makers

Updated August 20, 2020. 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.