Data / Medical devices / United States / MEDLINE INDUSTRIES - Mundelein
MEDLINE INDUSTRIES - Mundelein: FDA-registered device maker in Mundelein, IL, United States, 3 510(k) clearances
MEDLINE INDUSTRIES - Mundelein is registered with the FDA (registration 3013429260) in Mundelein, IL, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 6, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013429260
- FEI number
- 1000138386
- Address
- 1200 Townline Road One Medline Place, Mundelein, IL, United States, 60060
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 29, 1977
- Registered through
- 2026
- Brand names listed
- CURAD, Centurion Basin Kit, MEDLINE Needle, hypodermic, single lumen, MEDLINE Container, sharps, Medline, Medline Basin Kit, Medline Biohazard Specimen Bag, Medline Light Handle Cover and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Basin, Emesis | FNY | 1 | Manufacturer | accessdata.fda.gov |
| Bath, Sitz, Nonpowered | KTC | 1 | Manufacturer | accessdata.fda.gov |
| Bedpan | FOB | 1 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer | accessdata.fda.gov |
| Container, Sharps | MMK | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Contract manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Urinal | FNP | 1 | 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 |
|---|---|---|---|---|---|---|
| November 6, 2015 | K143693 | MEDLINE SHARPS CONTAINERS | MMK | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| February 3, 2014 | K132767 | MEDLINE SHARPS CONTAINER | MMK | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| July 5, 1995 | K951736 | LOCK-UP | FMI | Substantially Equivalent | Medline | accessdata.fda.gov |
Compare with other makers
- All makers of Bedpan
- All makers of Container, Sharps
- All makers of Container, Liquid Medication, Graduated
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Bath, Sitz, Nonpowered
- All makers of Basin, Emesis
Updated November 6, 2015. 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.