MiniMed Silhouette

GUDID 05705244019515

Single 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 ID05705244019515
NIH Device Record Key706bd284-8c11-4fac-a03f-dce9ff32240b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniMed Silhouette
Version Model NumberMMT-377A
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 Datetrue
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

Device Dimensions

Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 Centimeter
Depth17 Millimeter
Angle30 degree
Length110 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.

Device Identifiers

Device Issuing AgencyDevice ID
GS105705244019508 [Unit of Use]
GS105705244019515 [Package]
Contains: 05705244019522
Package: Outer box [200 Units]
In Commercial Distribution
GS105705244019522 [Primary]

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-19
Device Publish Date2019-07-11

On-Brand Devices [MiniMed Silhouette]

05705244019669Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244019638Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244019607Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244019577Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244019546Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244019515Single infusion set for subcutaneous infusion. The infusion set must be used as described in the
05705244019485Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025035Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025004Single use infusion set for subcutaneous infusion. The infusion set must be used as described in

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