FDA.reportPublic FDA data

HemCon® Patch PRO, 2in x 2in

Primary DI
20870053001859
Brand
HemCon® Patch PRO, 2in x 2in
Company
TRICOL BIOMEDICAL, INC.
Model
1
Catalog number
1005
Device description
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.
Published
2020-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080818000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080818000HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSINGHem Con Medical Technologies, Inc.2008-05-15QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20870053001859PackageGS110In Commercial Distribution
50870053001850PackageGS110In Commercial Distribution
00870053001855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2087005300185920870053001859
5087005300185050870053001850
00870053001855008700530018558700530018550870053001855

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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