HemCon® OneStop™ Vascular 1102
GUDID 00870053000322
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.
TRICOL BIOMEDICAL, INC.
Chitosan haemostatic agent| Primary Device ID | 00870053000322 |
| NIH Device Record Key | 79b811d1-0a8b-495c-bd76-a043ac13c9be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemCon® OneStop™ Vascular |
| Version Model Number | 1 |
| Catalog Number | 1102 |
| Company DUNS | 080240553 |
| Company Name | TRICOL BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
| Storage Environment Temperature | Between 11 Degrees Celsius and 26 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00870053000322 [Primary] |
| GS1 | 20870053000326 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 50870053000327 [Package] Contains: 20870053000326 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150916
FDA Product Code
| FRO | Dressing, Wound, Drug |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-30 |
| Device Publish Date | 2020-09-22 |
Devices Manufactured by TRICOL BIOMEDICAL, INC.
| 20870053000562 - ChitoGauzeXR PRO, 3in x 4yds | 2024-06-07 HemCon ChitoGauzeXR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds. |
| 20870053000401 - HemCon® OneStop® Vascular, 2in x 2in | 2022-04-13 The OneStop™ Dressing is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ dress |
| 20870053000418 - HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit | 2022-04-13 The OneStop™ Vascular Pre-Slit is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop |
| 20870053001033 - HemCon® Dental Dressing PRO, 10mm x 12mm | 2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o |
| 20870053001118 - HemCon® Dental Dressing PRO, 1in x 3in | 2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o |
| 00870053001268 - HemCon® Strip PRO, 1in x 4in | 2021-07-19 The HemCon® Strip PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon® Strip PR |
| 00870053000117 - GuardaCare®XR Surgical, 4in x 4in, 8ply | 2021-07-16 HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, n |
| 20870053000333 - HemCon® OneStop™ Bandage, 2in x 2in | 2021-05-13 The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandag |
Trademark Results [HemCon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMCON 76268991 2735347 Live/Registered |
TRICOL BIOMEDICAL, INC. 2001-06-07 |
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