tricolbiomedical.comChitoPulse 9in / 23 Cm, ChitoPulse 12in / 30.5 Cm, ChitoPulse 15in / 38 Cm
Tricol Biomedical Inc.
Tricol Biomedical, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004050854 | 3004050854 | Tricol Biomedical, INC. | 1 | N | 2026-01-01 | 720 SW Washington St Ste 200 PORTLAND OR US 97205 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00870053000117 | GuardaCare®XR Surgical, 4in x 4in, 8ply - 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. | 9712231000 | sales@tricolbiomedical.com |
| 00870053000322 | HemCon® OneStop™ Vascular - The OneStop™ Vascular is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The dressing 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. | 9712231000 | sales@tricolbiomedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 61158 | 1210696065 | K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm | DXC | 2017-08-29 |
| 61158 | 1253680323 | K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO | QSY | 2015-11-10 |
| 61158 | 1837535944 | K103641 | GUARDACARE | QSY | 2011-06-16 |
| 61158 | 1319823130 | K102546 | CHITOGAUZE | QSY | 2010-11-17 |
| 61158 | 2071099900 | K092357 | CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 | QSY | 2009-08-25 |
| 61158 | 1616632681 | K080818 | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING | QSY | 2008-05-15 |
| 61158 | 1226813988 | K060363 | HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12 | OLR | 2006-07-07 |
| 61158 | 1615978779 | K010933 | SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY | QSY | 2002-01-08 |
| 61158 | 1066320709 | ||||
| 61158 | 1432240113 |
Product Codes Associated With Registrations#
PMN#
GUDID#
HemCon® OneStop™ Vascular - The OneStop™ Vascular is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The dressing 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.
2020-09-22
HemCon GuardaCare® PRO, 2in x 2in, 8ply - HemCon GuardaCare PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
2020-12-10
GuardaCare® PRO, 4in x 4in, 8ply - HemCon GuardaCare PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
2021-04-14
HemCon® OneStop™ Bandage, 2in x 2in, OTC - OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulationtherapy. It also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
2021-05-05
GuardaCare®XR Surgical, 4in x 4in, 8ply - 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.
2021-07-08
HemCon® Strip PRO, 1in x 4in - The HemCon® Strip PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon® Strip PRO controls bleeding. The HemCon® Strip PRO 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.
2021-07-09
HemCon® Patch PRO, 2in x 2in - The HemCon Patch PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon Patch PRO controls bleeding caused by extreme trauma. The HemCon Patch PRO 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 baumanii. Only single strains of most species mentioned have been studied.
2020-10-14
HemCon® Patch PRO, 1.5in x 1.5in - The HemCon Patch PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon Patch PRO controls bleeding caused by extreme trauma. The HemCon Patch PRO 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 baumanii. Only single strains of most species mentioned have been studied.
2020-10-14
HemCon ChitoFlex®, 1in x 3in - The ChitoFlex PRO Hemostatic Dressing is manufactured from chitosan. When applied directly to the wound, the ChitoFlex PRO Hemostatic Dressing controls bleeding caused by extreme trauma. The ChitoFlex PRO Hemostatic Dressing 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.
2021-04-14
HemCon® Bandage PRO, 4in x 4in - The HemCon Bandage PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon Bandage PRO controls bleeding caused by external trauma. The HemCon Bandage PRO 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.
2020-10-14
ChitoGauzeXR PRO, 3in x 4yds - HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
2024-05-30
HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit - The OneStop™ Vascular Pre-Slit is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ dressing 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.
2022-04-05
HemCon® OneStop® Vascular, 2in x 2in - The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ dressing 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.
2022-04-05
HemCon® OneStop™ Bandage, 2in x 2in - The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The dressing 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.
2020-10-15
HemCon® OneStop™ Bandage, 2in x 2in - The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandage controls bleeding. The OneStop™ Bandage 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.
2021-05-05
HemCon ChitoGauze XR2 Pro, 3in x 4yd - HemCon® ChitoGauze® XR2 Pro is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
2021-04-14
ChitoGauzeXL, OTC, 3in x 4yd - ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
2021-04-14
ChitoGauze®, OTC, 3in x 48in - ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
2021-04-14
"ChitoGauze®XR PRO 3"" x 4 yds" - HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
2021-01-27
HemCon ChitoDot®, 3/4in - 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.
2021-04-14
"ChitoGauze®XR PRO 3"" x 4 yds Prometheus" - HemCon ChitoGauze®XR PRO is a haemostatic dressing for the external, temporary control of severely bleeding wounds.
2021-01-27
ChitoGauzeXR PRO, 3in x 4yds - HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
2024-05-30
HemCon® ChitoPulse™, 9 inch - 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.
2020-08-18
HemCon® ChitoPulse™, 15 inch - 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.
2020-08-18
HemCon® ChitoPulse™, 12 inch - 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.
2020-08-18
HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit - The OneStop™ Vascular Pre-Slit is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ dressing 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.
2022-04-05
HemCon® OneStop® Vascular, 2in x 2in - The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dressing controls bleeding. The OneStop™ dressing 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.
2022-04-05
HemCon® Dental Dressing PRO, 1in x 3in - The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
2021-07-09
HemCon® Dental Dressing PRO, 10mm x 12mm - The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
2021-07-09
HemCon® Dental Dressing PRO, 1in x 3in - The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
2021-07-09
HemCon® Dental Dressing PRO, 10mm x 12mm - The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
2021-07-09
HemCon® OneStop™ Bandage, 2in x 2in - The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandage controls bleeding. The OneStop™ Bandage 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.
2021-05-05
HemCon ChitoFlex®, 1in x 3in - The ChitoFlex PRO Hemostatic Dressing is manufactured from chitosan. When applied directly to the wound, the ChitoFlex PRO Hemostatic Dressing controls bleeding caused by extreme trauma. The ChitoFlex PRO Hemostatic Dressing 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.
2021-04-14
HemCon ChitoGauze XR2 Pro, 3in x 4yd - HemCon® ChitoGauze® XR2 Pro is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
2021-04-14
ChitoGauzeXL, OTC, 3in x 4yd - ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
2021-04-14
ChitoGauze®, OTC, 3in x 48in - ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
2021-04-14
HemCon ChitoDot®, 3/4in - 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.
2021-04-14
ChitoGauze®XR PRO 3" x 4 yds - HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
2021-01-27
ChitoGauze®XR PRO 3" x 4 yds Prometheus - HemCon ChitoGauze®XR PRO is a haemostatic dressing for the external, temporary control of severely bleeding wounds.
2021-01-27
HemCon® OneStop™ Bandage, 2in x 2in - The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The dressing 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.
2020-10-15