Data / Medical devices / United States / Medline Industries - Arlington Heights
Medline Industries - Arlington Heights: FDA-registered device maker in Arlington Heights, IL, United States, 9 510(k) clearances
Medline Industries - Arlington Heights is registered with the FDA (registration 1417411) in Arlington Heights, IL, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1417411
- Address
- 900 W. University Drive, Arlington Heights, IL, United States, 60004
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 3, 2016
- Registered through
- 2026
- Brand names listed
- Addipak Unit Dose Vial, Antimicrobial Wound Lavage, AquaPak Humidifier Adapters, Aquapak Humidifier Reservoir with Adaptor, Aquapak Nebulizer Reservoir with Adaptor, Aquapak Nebulizer; Aquapak Saline Reservoir; Aquapak Sterile Water Reservoir, Aquapak Sterile Humidifier Reservoirs, Comfort Flo Humidification System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Contract manufacturer | accessdata.fda.gov |
| Humidifier Nebulizer Kit | OGG | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Contract manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 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 |
|---|---|---|---|---|---|---|
| January 4, 2024 | K231058 | Hudson RCI® AddiPak® Unit Dose Vial | CAF | Substantially Equivalent | Medline Industries, LP | accessdata.fda.gov |
| July 26, 2016 | K153010 | Hudson RCI AquaPak Sterile Prefilled Nebulizers | CAF | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| April 29, 2015 | K142153 | HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML | CAF | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| December 18, 2014 | K141214 | AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS | CAF | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| August 1, 2014 | K141353 | HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR | BTT | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| May 24, 2000 | K993355 | HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 | BTT | Substantially Equivalent | Hudson Respiratory Care, Inc. | accessdata.fda.gov |
| May 3, 1982 | K820878 | CONCHO PEDIATRIC PACK | BTT | Substantially Equivalent | Rci, Inc. | accessdata.fda.gov |
| January 3, 1978 | K772348 | NEBULIZER ADAPTER | CAF | Substantially Equivalent | Respiratory Care, Inc. | accessdata.fda.gov |
| November 1, 1976 | K760866 | CONCHA-COLUMN | BTT | Substantially Equivalent | Respiratory Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Dressing, Wound, Drug
- All makers of Lavage, Jet
- All makers of Humidifier Nebulizer Kit
Updated January 4, 2024. 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.