Data / Medical devices / United States / Excelsior Medical LLC
Excelsior Medical LLC: FDA-registered device maker in Freehold, NJ, United States, 5 510(k) clearances
Excelsior Medical LLC is registered with the FDA (registration 3008518459) in Freehold, NJ, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008518459
- Address
- 317 Fairfield Road, Freehold, NJ, United States, 07728
- Owner or operator
- Medline Industries, LP (9000300)
- Roles
- Repackager or relabeler
- First device listed
- January 8, 2009
- Registered through
- 2026
- Brand names listed
- 0.9% Sodium Chloride Injection, USP, 0.9% Sodium Chloride Injection, USP, Pre-Filled COP Syringe, Heparin Lock Flush, USP, Saline FLush For Sterile Field, Saline Flush Syringe, SwabFlush
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cap, Device Disinfectant | QBP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Heparin, Vascular Access Flush | NZW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Saline, Vascular Access Flush | NGT | 2 | 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 |
|---|---|---|---|---|---|---|
| September 15, 2019 | K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe | NGT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| June 21, 2018 | K173348 | 0.9% Sodium Chloride Injection, USP | NGT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| November 14, 2014 | K133446 | HEPARIN LOCK / FLUSH SYRINGES | NZW | Substantially Equivalent | Excelsior Medical Corporation | accessdata.fda.gov |
| December 24, 2013 | K130975 | SWABCAP AND SWABFLUSH | QBP | Substantially Equivalent | Excelsior Medical Corp. | accessdata.fda.gov |
| December 18, 2008 | K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) | NGT | Substantially Equivalent | Excelsior Medical Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Cap, Device Disinfectant
- All makers of Saline, Vascular Access Flush
- All makers of Heparin, Vascular Access Flush
Updated September 15, 2019. 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.