Paramount Mini GPS PMB8-5-18-80

GUDID 00821684006597

Balloon-Expandable Biliary Stent System

Covidien LP

Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent Bare-metal biliary stent

• Primary Device ID: 00821684006597
• NIH Device Record Key: f333a3da-f380-40bd-a40f-8ae2250d404f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paramount Mini GPS
• Version Model Number: PMB8-5-18-80
• Catalog Number: PMB8-5-18-80
• Company DUNS: 968903703
• Company Name: Covidien LP
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French
• Outer Diameter: 5 Millimeter
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821684006597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040653

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

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: 2015-10-16

On-Brand Devices [Paramount Mini GPS]

• 00821684006641: Balloon-Expandable Biliary Stent System
• 00821684006634: Balloon-Expandable Biliary Stent System
• 00821684006627: Balloon-Expandable Biliary Stent System
• 00821684006610: Balloon-Expandable Biliary Stent System
• 00821684006603: Balloon-Expandable Biliary Stent System
• 00821684006597: Balloon-Expandable Biliary Stent System
• 00821684006580: Balloon-Expandable Biliary Stent System
• 00821684006573: Balloon-Expandable Biliary Stent System
• 00821684006566: Balloon-Expandable Biliary Stent System
• 00821684006467: Balloon-Expandable Biliary Stent System
• 00821684006450: Balloon-Expandable Biliary Stent System
• 00821684006443: Balloon-Expandable Biliary Stent System
• 00821684006436: Balloon-Expandable Biliary Stent System
• 00821684006429: Balloon-Expandable Biliary Stent System
• 00821684006412: Balloon-Expandable Biliary Stent System
• 00821684006405: Balloon-Expandable Biliary Stent System
• 00821684006399: Balloon-Expandable Biliary Stent System
• 00821684006382: Balloon-Expandable Biliary Stent System