LineLogic™

GUDID 10851780008208

Sterile, Linelogic™ 8.5 Fr Catheter Stabilization Device

SMD Manufacturing 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

• Primary Device ID: 10851780008208
• NIH Device Record Key: d218334b-d4bd-446c-9edb-c33595cd58f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LineLogic™
• Version Model Number: LL-M-8
• Company DUNS: 070849038
• Company Name: SMD Manufacturing 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health
• Phone: +1 (801) 899-3036
• Email: info@linelogic.health

Device Dimensions

• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French
• Catheter Gauge: 8.6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851780008201 [Primary]
GS1	10851780008208 [Package]; Contains: 00851780008201; Package: Box [10 Units]; In Commercial Distribution
GS1	20851780008205 [Package]; Package: Case [2 Units]; In Commercial Distribution
GS1	30851780008202 [Package]; Contains: 20851780008205; Package: Overshipper [16 Units]; In Commercial Distribution

FDA Product Code

• KMK: Device, Intravascular Catheter Securement

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: 2022-08-09
• Device Publish Date: 2022-08-01

On-Brand Devices [LineLogic™]

• 10851780008208: Sterile, Linelogic™ 8.5 Fr Catheter Stabilization Device
• 10851780008109: Sterile, Linelogic™ 7 Fr Catheter Stabilization Device
• 10851780008000: Sterile, Linelogic™ 6 Fr Catheter Stabilization Device