Silhouette® Paradigm®

GUDID 05705244008731

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

Unomedical A/S

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Primary Device ID	05705244008731
NIH Device Record Key	0d630357-545e-4cc7-a838-aca59ca41f6e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Silhouette® Paradigm®
Version Model Number	MMT-378600
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	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 Millimeter
Angle	30 degree
Length	60 Centimeter
Depth	17 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	05705244008731 [Primary]
GS1	05705244008748 [Package] Package: Outer box [200 Units] In Commercial Distribution
GS1	05705244012912 [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