FDA.reportPublic FDA data

HemCon® OneStop™ Vascular

Primary DI
00870053000322
Brand
HemCon® OneStop™ Vascular
Company
TRICOL BIOMEDICAL, INC.
Model
1
Catalog number
1102
Device description
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.
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150916000HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PROHem Con Medical Technologies, Inc.2015-11-10QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20870053000326PackageGS110In Commercial Distribution
50870053000327PackageGS110In Commercial Distribution
00870053000322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2087005300032620870053000326
5087005300032750870053000327
00870053000322008700530003228700530003220870053000322

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agentA sterile, non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature11 Degrees Celsius26 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9712231000sales@tricolbiomedical.com

Regulatory Flags#

DUNS number
080240553
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00870053000018"ChitoGauze®XR PRO 3"" x 4 yds Prometheus"110892021-01-27
00870053000049HemCon ChitoDot®, 3/4in110932021-04-14
00870053000131"ChitoGauze®XR PRO 3"" x 4 yds"110902021-01-27
00870053000292ChitoGauze®, OTC, 3in x 48in110302021-04-14
00870053000308ChitoGauzeXL, OTC, 3in x 4yd110252021-04-14
00870053000315HemCon ChitoGauze XR2 Pro, 3in x 4yd111012021-04-14
00870053000339HemCon® OneStop™ Bandage, 2in x 2in111052021-05-05
00870053000353HemCon® OneStop™ Bandage, 2in x 2in111142020-10-15
00870053000407HemCon® OneStop® Vascular, 2in x 2in111032022-04-05
00870053000414HemCon® OneStop® Vascular, 1.5in x 1.5in, Pre-Slit111042022-04-05
00870053000568ChitoGauzeXR PRO, 3in x 4yds110202024-05-30
00870053001015HemCon® Bandage PRO, 4in x 4in110032020-10-14
00870053001121HemCon ChitoFlex®, 1in x 3in110082021-04-14
00870053001299HemCon® Patch PRO, 1.5in x 1.5in110042020-10-14
00870053001855HemCon® Patch PRO, 2in x 2in110052020-10-14
00870053001268HemCon® Strip PRO, 1in x 4in12021-07-09
00870053000117GuardaCare®XR Surgical, 4in x 4in, 8ply110322021-07-08
00870053000360HemCon® OneStop™ Bandage, 2in x 2in, OTC111122021-05-05
00870053001367GuardaCare® PRO, 4in x 4in, 8ply110132021-04-14
00870053001350HemCon GuardaCare® PRO, 2in x 2in, 8ply110122020-12-10

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