HemCon ChitoDot®, 3/4in 1093

GUDID 20870053000043

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.

TRICOL BIOMEDICAL, INC.

Chitosan haemostatic agent, professional

• Primary Device ID: 20870053000043
• NIH Device Record Key: fad22f8b-0aab-40c2-89f9-75f45e0df8d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemCon ChitoDot®, 3/4in
• Version Model Number: 1
• Catalog Number: 1093
• 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

• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00870053000049 [Primary]
GS1	20870053000043 [Package]; Contains: 00870053000049; Package: Box [50 Units]; In Commercial Distribution
GS1	50870053000044 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150916

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2021-04-22
• Device Publish Date: 2021-04-14

Devices Manufactured by TRICOL BIOMEDICAL, INC.

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• 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