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THE clear solution FOR INFECTION PROTECTION THE next generation OF WOUND CARE PRODUCTS easy to use flexible microbial barrier
THE clear solution FOR INFECTION PROTECTION
THE next generation OF WOUND CARE PRODUCTS
easyto use
flexible
microbialbarrier
LBL049.02
NUVADERM INDICATIONS
O R D E R I N G I N F O R M AT I O N
THE next generation OF WOUND CARE PRODUCTS
REFE
RENC
ES
WWW.BEEKENBIOMEDICAL.COM
• NUVADERM received market clearance in the form of a 510[k] from the United States Food and Drug Administration CDRH [Center for Devices and Radiological Health] in 2009 [Nuvaderm 510k K083913, 07/31/2009].
• The product’s cleared intended use is “to cover intact skin or minor cuts, scrapes, burns and irritations of the skin, to help keep them clean, and dry, and help protect them from infection.”
1) IFU, 20132) Internal Report P200902433) NUVADERM MSDS 2012. P1012-044) Internal Report 809611: ASTM E 2315
5) Internal Report 77051494756) Huntsman Polyurea Technical Document7) Guan, “100% Polyurethane and Polyurea Coatings Technology,”
Coatings World, March 2003.8) FDA Filing Packet, 2009 and Review Board Document 2012
NUVADERM is an easy to use, flexible liquid dressing designed to cover wounds and protect against infection. Nuvaderm's patented, high performance design, protects wounds effectively for improved wound healing.
COMPOSITION:• Poly[Urea-Urethane]
• Organic Solvents (Acetone, Methylethyl Ketone)
KILLS INFECTION
FLEXIBLE
WATERPROOF
SAFE
TRANSPARENT
Kills a broad spectrum of infective agents at a rate greater than 99.9%
Conforms to irregular geometries and flexes without detaching
Creates a waterproof barrier upon application
Non–toxic. Wears off naturally and does not impede wound healing.
Allows for clear visualization of the wound as it heals
ORGANISM COMMON POPULATION 30 SECOND 30 MINUTE CONTROLS COUNT (% REDUCTION) (% REDUCTION)
Staphylococcus Bacteria > 108 > 99.99% > 99.99%
No aureus (MRSA) Reduction
Escherichia coli
Bacteria > 108 > 99.99% > 99.99%
No Reduction
Pseudomonas Bacteria > 108 > 99.99% > 99.99% 8.33% – No aeruginosa Reduction
Candida Yeast > 108 > 99.99% > 99.99% No albicans Reduction
Aspergillus Mold > 107 > 99.99% > 99.99% No brasiliensis Reduction
NUVADERM was tested against five standard organisms from USP 51 to determine its antimicrobial effectiveness.
888.497.7376 (Phone)866.724.3396 (Fax)
127 West Hargett St., Suite 300Raleigh, NC 27601
CUSTOMER SERVICETo request a Nuvaderm evaluation contact:
ORDER CODE SIZE DESCRIPTION
575-12B 7.5mL 12 – Nuvaderm vials w/ spray device
515-12B 15mL 12 – Nuvaderm vials w/ spray device
