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

Electric infusion pump administration set, single-use
Primary Device ID05705244008731
NIH Device Record Key0d630357-545e-4cc7-a838-aca59ca41f6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilhouette® Paradigm®
Version Model NumberMMT-378600
Company DUNS306032491
Company NameUnomedical A/S
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx
Phone1-800-646-4633
Emailxx@xx.xx

Device Dimensions

Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree
Length60 Centimeter
Depth17 Millimeter
Angle30 degree

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 AgencyDevice ID
GS105705244008731 [Primary]
GS105705244008748 [Package]
Package: Outer box [200 Units]
In Commercial Distribution
GS105705244012912 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-15

On-Brand Devices [Silhouette® Paradigm®]

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

Trademark Results [Silhouette]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILHOUETTE
SILHOUETTE
98864114 not registered Live/Pending
Abedan Kanthasamy
2024-11-20
SILHOUETTE
SILHOUETTE
98606728 not registered Live/Pending
Deer:30, LLC
2024-06-18
SILHOUETTE
SILHOUETTE
98369461 not registered Live/Pending
Grand Design RV, LLC
2024-01-22
SILHOUETTE
SILHOUETTE
98075932 not registered Live/Pending
MATTEL, INC.
2023-07-07
SILHOUETTE
SILHOUETTE
97539106 not registered Live/Pending
Silhouette by Alexis LLC
2022-08-08
SILHOUETTE
SILHOUETTE
97539096 not registered Live/Pending
Silhouette by Alexis LLC
2022-08-08
SILHOUETTE
SILHOUETTE
97282931 not registered Live/Pending
Union Square Credit Union
2022-02-24
SILHOUETTE
SILHOUETTE
97249115 not registered Live/Pending
Honeylove Sculptwear, Inc.
2022-02-01
SILHOUETTE
SILHOUETTE
90862447 not registered Live/Pending
Drew Layne, LLC
2021-08-03
SILHOUETTE
SILHOUETTE
90700749 not registered Live/Pending
Landscape Forms, Inc.
2021-05-10
SILHOUETTE
SILHOUETTE
90330898 not registered Live/Pending
B Kay's Interiors & Coffee House
2020-11-19
SILHOUETTE
SILHOUETTE
90056765 not registered Live/Pending
Grand Design RV, LLC
2020-07-16

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