Silhouette® Paradigm®

GUDID 05705244008878

Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.

Unomedical A/S

Electric infusion pump administration set, single-use

• Primary Device ID: 05705244008878
• NIH Device Record Key: ea01c34b-9418-4e88-bc17-c36c865e9898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silhouette® Paradigm®
• Version Model Number: MMT-383600
• Company DUNS: 306032491
• Company Name: Unomedical A/S
• Device Count: 10
• 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: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx
• Phone: 1-800-646-4633
• Email: xx@xx.xx

Device Dimensions

• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree
• Length: 80 Centimeter
• Depth: 13 Millimeter
• Angle: 30 degree

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle
• Special Storage Condition, Specify: Between 0 and 0 *Store infusion sets in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle

Device Identifiers

Device Issuing Agency	Device ID
GS1	05705244008878 [Primary]
GS1	05705244008885 [Package]; Package: Outer box [200 Units]; In Commercial Distribution
GS1	05705244013001 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002138

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-15

On-Brand Devices [Silhouette® Paradigm®]

• 05705244009332: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244009318: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244009165: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244009141: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244009035: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244009011: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244008892: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244008878: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244008755: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244008731: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244008588: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244008564: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244008434: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244008410: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in