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.

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• 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