Address:720 SW Washington St Ste 200,PORTLAND,OR,97205,US
Device Description : HemCon ChitoGauze®XR PRO is a haemostatic dressing for the external, temporary c HemCon ChitoGauze®XR PRO is a haemostatic dressing for the external, temporary control of severely bleeding wounds.
Device Class : U
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : Yes
Device Description : The HemCon ChitoDot is a bandage manufactured from chitosan. When applied direct The HemCon ChitoDot is a bandage manufactured from chitosan. When applied directly to the wound, the HemCon ChitoDot controls bleeding. The HemCon ChitoDot offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
Device Class :
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : Yes
Device Description : ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch th ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when positioned directly onto an access site, applies localized mechanical pressure to promote hemostasis and rapid control of bleeding. The chitosan patch acts as an adjunct to the mechanical compression provided by the adjustable strap and compression balloon to aid the control of bleeding. Using the inflation syringe, the compression applied by the device can be controlled by the user without unfastening the band, allowing gradual release of compression as hemostasis occurs. ChitoPulse™ is a single use device. Once hemostasis is achieved, the adjustable band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing and left in situ for up to 24 hrs. ChitoPulse™ also provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
Device Class :
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : Yes
Device Description : ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch th ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when positioned directly onto an access site, applies localized mechanical pressure to promote hemostasis and rapid control of bleeding. The chitosan patch acts as an adjunct to the mechanical compression provided by the adjustable strap and compression balloon to aid the control of bleeding. Using the inflation syringe, the compression applied by the device can be controlled by the user without unfastening the band, allowinggradual release of compression as hemostasis occurs. ChitoPulse™ is a single use device. Once hemostasis is achieved, the adjustable band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing and left in situ for up to 24 hrs. ChitoPulse™ also provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
Device Class :
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : Yes
Device Description : HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing compris HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, non-woven, medical-grade gauze, and a single radio- opaque element. The dressing is z-folded and packaged in a sterile double pouch.
Device Class :
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : Yes
Device Description : HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary con HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Device Class : U
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : Yes
Device Description : ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch th ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when positioned directly onto an access site, applies localized mechanical pressure to promote hemostasis and rapid control of bleeding. The chitosan patch acts as an adjunct to the mechanical compression provided by the adjustable strap and compression balloon to aid the control of bleeding. Using the inflation syringe, the compression applied by the device can be controlled by the user without unfastening the band, allowing gradual release of compression as hemostasis occurs. ChitoPulse™ is a single use device. Once hemostasis is achieved, the adjustable band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing and left in situ for up to 24 hrs. ChitoPulse™ also provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
Device Class :
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : Yes
Device Description : ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
Device Class : U
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : No
Device Description : ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
Device Class : U
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : No
Device Description : HemCon® ChitoGauze® XR2 Pro is a hemostatic dressing for the external, temporary HemCon® ChitoGauze® XR2 Pro is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
Device Class : U
Duns Number: 080240553
Premarket Exempt : No
Prescription Use : Yes