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Data / Medical devices / United States / Intent Brands LLC

Intent Brands LLC: FDA-registered device maker in Falls Church, VA, United States, 1 510(k) clearance

Intent Brands LLC is registered with the FDA (registration 3031288561) in Falls Church, VA, United States. It lists 24 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 10, 2022. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Intent Brands LLC
FDA registration number
3031288561
Address
308 Walnut Street, Falls Church, VA, United States, 22046
Owner or operator
Intent Brands LLC (10090739)
Roles
Repackager or relabeler
First device listed
May 13, 2024
Registered through
2026
Brand names listed
SurviveX Alcohol Pad, SurviveX Bandage, SurviveX Blue Elastic Wound Tape, SurviveX Burn Dressing, SurviveX Burn Gel/Hydro Gel (3.5g), SurviveX Burn Kit, SurviveX CPR Mask, SurviveX Chest Seal and more

Devices it lists

DeviceProduct codeClassRoleSource
Adhesive Backed Thermal Skin PatchesOMW1Repackager or relabeleraccessdata.fda.gov
Airway, NasopharyngealBTQ1Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Clip, Removable (Skin)FZQ1Repackager or relabeleraccessdata.fda.gov
Dressing, CompressionMHW1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Repackager or relabeleraccessdata.fda.gov
First Aid Kit Without DrugOHO1Repackager or relabeleraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYURepackager or relabeleraccessdata.fda.gov
Lubricant, PatientKMJ1Repackager or relabeleraccessdata.fda.gov
Mouthpiece, BreathingBYP1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Pad, Alcohol, Device DisinfectantLKBURepackager 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
Splint, Hand, And ComponentsILH1Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Repackager or relabeleraccessdata.fda.gov
Tape, OrthopedicHXT1Repackager or relabeleraccessdata.fda.gov
Valve, Non-RebreathingCBP2Repackager 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
February 10, 2022K211570Zeolite Hemostatic GauzeQSYSubstantially EquivalentHangzhou Zeo-Innov Life Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated February 10, 2022. 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.