Pensar Medical Wound Pro Sting Ray NPWT Wound Dressing: Buyers Beware
Make Sure To Conduct Due Diligence on a Medicare PDAC and FDA 510K approval on Pensar Medical WoundPro Dressing Foam Kits.
Before doing business with Pensar Medical, make sure that Pensar Medical has the proper FDA 510K clearance to sell and market its WoundPro Dressing Kits. According to the FDA 510K Search Data Base, Pensar Medical DOES NOT have a FDA 510K clearance for its WoundPro Dressing kit.
Check the FDA 510K Search Data Base:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Call the FDA and Check :
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA1-888-INFO-FDA FREE (1-888-463-63321-888-463-6332 FREE)
Make sure to report this to the FDA immediately
Before doing business with Pensar Medical, make sure that Pensar Medical has the proper Medicare PDAC approval. According to the Noridian, Medicare Pricing Data Analysis and Coding office, Pensar Medical DOES NOT have Medicare PDAC approval for its WoundPro Dressing Kit.
Check the Noridian Search Data Base:
https://www.dmepdac.com/dmecsapp/do/search
Call Noridian and Check:
PDAC
PO Box 6757
Fargo ND 58108-6757
Contact Center
877.735.1326877.735.1326 FREE Toll Free
Email a compliant to Noridian immediately:
PDAC@noridian.com
Proprietary Name: | Alaira; Apex Wound Pro |
Classification Name: | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
Product Code: | OMP |
Device Class: | 2 |
Regulation Number: | 878.4780 |
Medical Specialty: | General & Plastic Surgery |
Registered Establishment Name: | Pensar Medical, LLC |
Registered Establishment Number: | 3007793449 |
Premarket Submission Number: | K100823 |
Owner/Operator: | Pensar Medical |
Owner/Operator Number: | 10043309 |
Establishment Operations: | Manufacturer; Remanufacturer; Specification Developer; U.S. Manufacturer of Export Only Devices
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