Data / Medical devices / United States / Luv N' Care, Ltd.
Luv N' Care, Ltd.: FDA-registered device maker in Monroe, LA, United States, 3 510(k) clearances
Luv N' Care, Ltd. is registered with the FDA (registration 2381321) in Monroe, LA, United States. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 24, 2010. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2381321
- Address
- 3030 Aurora Ave FL 2nd, Monroe, LA, United States, 71201
- Owner or operator
- LUV N' CARE, LTD. (2381321)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- July 27, 1995
- Registered through
- 2026
- Brand names listed
- Breast Soothing Pads, Chewbies, Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils), Electronic Thermometer, Manual Breast Pump, Medi-Nurser, Nipple Protector, Nuby Icy Bite Gel Teether and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrophoretic Method, Catecholamines | CHT | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Nipple, Lambs Feeding | FNN | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Shield, Nipple | HFS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Repackager or relabeler | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2010 | K100385 | NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP | HGX | Substantially Equivalent | Luv N' Care, Ltd. | accessdata.fda.gov |
| March 1, 2010 | K092494 | GEL FILLED GUM SOOTHER | KKO | Substantially Equivalent | Luv N' Care, Ltd. | accessdata.fda.gov |
| November 21, 2002 | K023711 | DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE | FLL | Substantially Equivalent | Acute Ideas Co. , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 17, 2009 | 52708 | Not yet classified | Terminated | Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for medical purposes to soothe gums during the teething process. | Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Toothbrush, Manual
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Pump, Breast, Powered
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Dispenser, Liquid Medication
Updated March 24, 2010. 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.