HemCon® OneStop™ Bandage, 2in x 2in 1105

GUDID 20870053000333

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.

TRICOL BIOMEDICAL, INC.

Chitosan haemostatic agent, professional

• Primary Device ID: 20870053000333
• NIH Device Record Key: e11f69bd-641a-4070-a626-cb0ab24224c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemCon® OneStop™ Bandage, 2in x 2in
• Version Model Number: 1
• Catalog Number: 1105
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00870053000339 [Primary]
GS1	20870053000333 [Package]; Contains: 00870053000339; Package: Box [10 Units]; In Commercial Distribution
GS1	50870053000334 [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: 2021-05-13
• Device Publish Date: 2021-05-05

On-Brand Devices [HemCon® OneStop™ Bandage, 2in x 2in]

• 50870053000358: The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to
• 20870053000333: The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to