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Pensar Medical Wound Pro Pump wound dressing might not have FDA approval

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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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