Tru-Fix Catheter Fixation Kit TFK-14

GUDID H862TFK142

Tru-Fix Catheter Fixation Kit - 14F

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

• Primary Device ID: H862TFK142
• NIH Device Record Key: d146c4bd-82cb-47c7-812b-fb05ab0d59e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tru-Fix Catheter Fixation Kit
• Version Model Number: TFK-14
• Catalog Number: TFK-14
• 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
• 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
• 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: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H862TFK140 [Primary]
HIBCC	H862TFK141 [Package]; Contains: H862TFK140; Package: Dispenser [5 Units]; In Commercial Distribution
HIBCC	H862TFK142 [Package]; Contains: H862TFK141; Package: Shipper [5 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-08-31

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

• H862TFK162: Tru-Fix Catheter Fixation Kit - 16F
• 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