Data / Medical devices / United States / Professional Disposables International, Inc.
Professional Disposables International, Inc.: FDA-registered device maker in Woodcliff Lake, NJ, United States, 1 510(k) clearance
Professional Disposables International, Inc. is registered with the FDA (registration 3015361761) in Woodcliff Lake, NJ, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 27, 2014. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015361761
- Address
- 400 Chestnut Ridge Road, Woodcliff Lake, NJ, United States, 07677
- Owner or operator
- Professional Disposables International, Inc. (2411192)
- Roles
- Complaint file establishment
- First device listed
- March 24, 2010
- Registered through
- 2027
- Brand names listed
- Hygea Sterile Saline Wipe, PDI Adhesive Tape Remover Pad, PREVANTICS DEVICE LARGE SWAB, PREVANTICS DEVICE SWAB, PREVANTICS DEVICE SWAB STRIP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Complaint file establishment | accessdata.fda.gov |
| Solvent, Adhesive Tape | KOX | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| August 27, 2014 | K132380 | PREVANTICS DEVICE SWAB | LKB | Substantially Equivalent | Professional Disposables International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pad, Alcohol, Device Disinfectant
- All makers of Fiber, Medical, Absorbent
- All makers of Solvent, Adhesive Tape
Updated August 27, 2014. 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.