Data / Medical devices / United States / Medline Industries, LP - ReadyCare Hartland
Medline Industries, LP - ReadyCare Hartland: FDA-registered device maker in Hartland, WI, United States, 2 510(k) clearances
Medline Industries, LP - ReadyCare Hartland is registered with the FDA (registration 3011508621) in Hartland, WI, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 21, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011508621
- Address
- 700 W North Shore Dr, Hartland, WI, United States, 53029
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Manufacturer
- First device listed
- October 24, 2016
- Registered through
- 2027
- Brand names listed
- 0.9% Sodium Chloride Injection, USP, Aplicare Lubricating Jelly; Aplicare Lubricating Jelly Packets; Dover Lubricating Jelly; Operand Lubricating Jelly, Medline Wipes, Micro-Kill Wipes and Solutions
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Jelly, Lubricating, For Transurethral Surgical Instrument | FHX | 2 | Manufacturer | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| June 21, 2018 | K173348 | 0.9% Sodium Chloride Injection, USP | NGT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| August 7, 1991 | K912132 | OPERAND LUBRICATING JELLY | FHX | Substantially Equivalent | General Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Disinfectant, Medical Devices
- All makers of Saline, Vascular Access Flush
- All makers of Jelly, Lubricating, For Transurethral Surgical Instrument
Updated June 21, 2018. 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.