GUDID 10858778006093

1.9Fr Dual Lumen Polyurethane PIC Catheter

FOOTPRINT MEDICAL, INC.

Peripherally-inserted central venous catheter

• Primary Device ID: 10858778006093
• NIH Device Record Key: c7225b50-c74e-44a0-a384-2888916bb4ea
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: P2PIC1.9-C
• 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: 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

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	00858778006096 [Primary]
GS1	10858778006093 [Package]; Contains: 00858778006096; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130507

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

Devices Manufactured by FOOTPRINT MEDICAL, INC.

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• 10859950007464 - NA: 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 5.0Fr by 40cm
• 10859950007471 - NA: 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 6.5Fr by 40cm
• 10859950007488 - NA: 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 8.0Fr by 40cm
• 10859950007495 - NA: 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 4.0Fr by 60cm
• 10859950007501 - NA: 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 5.0Fr by 60cm
• 10859950007518 - NA: 2022-10-07 Polyurethane Feeding Tube with male Enteral Connector 6.5Fr by 60cm