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Data / Medical devices / United States / Aero Healthcare

Aero Healthcare: FDA-registered device maker in Valley Cottage, NY, United States, 3 510(k) clearances

Aero Healthcare is registered with the FDA (registration 3009540516) in Valley Cottage, NY, United States. It lists 30 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Aero Healthcare
FDA registration number
3009540516
Address
616 Corporate Way Ste 6, Valley Cottage, NY, United States, 10989
Owner or operator
Aero Healthcare (10040045)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
March 3, 2012
Registered through
2026
Brand names listed
AERO, AEROBAN Cohesive Bandage, AEROBAND Triangular Bandage, AEROBURN, AEROBURN Packets, 4"x4" Dressing, AEROFILM Waterproof Film Dressing, AEROFORM Conforming Bandage, AEROGLOVE Nitrile Glove and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Bag, IntestineKGY1Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Dressing, CompressionMHW1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Repackager or relabeleraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Repackager or relabeleraccessdata.fda.gov
Finger CotLZB1Repackager or relabeleraccessdata.fda.gov
First Aid Kit With DrugLRRNManufacturer, Repackager or relabeleraccessdata.fda.gov
First Aid Kit Without DrugOHO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Repackager 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
Sheet, BurnFPY1Repackager or relabeleraccessdata.fda.gov
Sling, ArmILI1Repackager or relabeleraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Repackager or relabeler, Specification developeraccessdata.fda.gov
Strip, Temperature, Forehead, Liquid CrystalKPD2Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Thermometer, Clinical Color ChangeFQZ1Repackager or relabeleraccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Manufactureraccessdata.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 11, 2023K231408Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-SterileLZASubstantially EquivalentShandong Intco Medical Products Co, Ltd.accessdata.fda.gov
July 12, 2018K172874Infrared ThermometerFLLSubstantially EquivalentShenzhen Jiacom Technology CO ., Ltd.accessdata.fda.gov
December 4, 1998K983825NITRILE LATEX POWDER FREE EXAMINATION GLOVELZASubstantially EquivalentTop Glove Sdn. Bhd.accessdata.fda.gov

Compare with other makers

Updated August 11, 2023. 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.