Tru-Fix Catheter Fixation Kit TFK-06

GUDID 10817640020643

Tru-Fix Catheter Fixation Kit - 6F

URESIL, LLC

Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder

• Primary Device ID: 10817640020643
• NIH Device Record Key: 23232896-de23-42ad-9a35-cba8f7e5c15d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tru-Fix Catheter Fixation Kit
• Version Model Number: TFK-06
• Catalog Number: TFK-06
• Company DUNS: 192559557
• Company Name: URESIL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com
• Phone: 1-800-538-7374
• Email: sales@uresil.com

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817640020646 [Primary]
GS1	10817640020643 [Package]; Contains: 00817640020646; Package: Dispenser [5 Units]; In Commercial Distribution
GS1	20817640020640 [Package]; Package: Shipper [5 Units]; In Commercial Distribution
HIBCC	H862TFK060 [Previous]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

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: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [Tru-Fix Catheter Fixation Kit]

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• H862TFK142: Tru-Fix Catheter Fixation Kit - 14F
• H862TFK122: Tru-Fix Catheter Fixation Kit - 12F
• H862TFK102: Tru-Fix Catheter Fixation Kit - 10F
• H862TFK082: Tru-Fix Catheter Fixation Kit - 8F
• H862TFK062: Tru-Fix Catheter Fixation Kit - 6F
• H862TFDR2: Tru-Fix Fixation Dressing Replacement
• 10817640020698: Tru-Fix Catheter Fixation Kit - 16F
• 10817640020681: Tru-Fix Catheter Fixation Kit - 14F
• 10817640020674: Tru-Fix Catheter Fixation Kit - 12F
• 10817640020667: Tru-Fix Catheter Fixation Kit - 10F
• 10817640020650: Tru-Fix Catheter Fixation Kit - 8F
• 10817640020643: Tru-Fix Catheter Fixation Kit - 6F
• 10817640020636: Tru-Fix Fixation Dressing Replacement