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Data / Medical devices / United States / Fridababy, LLC

Fridababy, LLC: FDA-registered device maker in Jacksonville, FL, United States, 1 510(k) clearance

Fridababy, LLC is registered with the FDA (registration 3030726486) in Jacksonville, FL, United States. It lists 21 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2017. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Fridababy, LLC
FDA registration number
3030726486
Address
11007 Development Way, Jacksonville, FL, United States, 32220
Owner or operator
Fridababy, LLC (10052488)
Roles
Repackager or relabeler
First device listed
November 18, 2016
Registered through
2027
Brand names listed
3-in-1 Ear, Forehead, + Touchless Thermometer, 3-in-1 True Temp Thermometer, Baby Basics Kit, Baby Grooming Kit, Bath Accessories Kit, US,, Big Bundle of Joy, Bitty Bundle of Joy, Breast Care Self Care Kit and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, VaginalHGD1Repackager or relabeleraccessdata.fda.gov
Attachment, Commode, WheelchairINB1Repackager or relabeleraccessdata.fda.gov
Brush, Dermabrasion, ManualGED1Repackager or relabeleraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Repackager or relabeleraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Repackager or relabeleraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Repackager or relabeleraccessdata.fda.gov
Dilator, RectalFFP1Repackager or relabeleraccessdata.fda.gov
Dispenser, Liquid MedicationKYX1Repackager or relabeleraccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Repackager or relabeleraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Repackager or relabeleraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Repackager or relabeleraccessdata.fda.gov
Nasal Spray, Ent DeliveryKCO1Repackager or relabeleraccessdata.fda.gov
Nursing Pad, HydrogelNTC1Repackager or relabeleraccessdata.fda.gov
Orthosis, AbdominalKTD1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Repackager or relabeleraccessdata.fda.gov
Ring, Teething, Fluid-FilledKKO2Repackager or relabeleraccessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The CounterNGE1Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeleraccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Repackager 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
December 22, 2017K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)JHISubstantially EquivalentTrue Diagnostics, Inc.accessdata.fda.gov

Compare with other makers

Updated December 22, 2017. 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.