Silhouette® Paradigm®

Basic Information

• Brand Name: Silhouette® Paradigm®
• Primary DI: 05705244009035
• Version / Model: MMT-384
• Company Name: Unomedical A/S
• Labeler DUNS: 306032491
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2021-09-13
• Public Version Status: Update
• Public Device Record Key: 2535488c-d914-43f4-8ff6-21657ee890c2

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35833	Electric infusion pump administration set, single-use	A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05705244009035	GS1
Unit of Use	05705244013100	GS1
Package	05705244009042	GS1	Outer box	200	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002138	000

Device Sizes

Type	Value	Unit	Text
Length	80	Centimeter
Depth	17	Millimeter
Angle	30	degree

Storage Conditions

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