GUDID 10858778006048

1.9Fr Single Lumen Silicone PIC Catheter Kit

FOOTPRINT MEDICAL, INC.

Peripherally-inserted central venous catheter

• Primary Device ID: 10858778006048
• NIH Device Record Key: 4f8a6c19-fcf5-4fed-b383-0c65fb69dbcb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: S1PIC1.9-S
• Company DUNS: 791238046
• Company Name: FOOTPRINT MEDICAL, 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: true
• 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: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com
• Phone: 2102262600
• Email: info@footprintmed.com

Device Dimensions

• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French
• Catheter Gauge: 1.9 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858778006041 [Primary]
GS1	10858778006048 [Package]; Contains: 00858778006041; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093252

FDA Product Code

• LJS: Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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