Mio Advance

GUDID 05705244021792

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 ID05705244021792
NIH Device Record Keyf81dbadb-0634-4e2d-aa6e-fd48f6c44940
Commercial Distribution StatusIn Commercial Distribution
Brand NameMio Advance
Version Model NumberMMT-248
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

Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
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Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
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Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
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Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
Phone9999999999
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Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
Phone9999999999
Emailxx@xx.xx
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Device Dimensions

Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree
Length110 Centimeter
Depth9 Millimeter
Angle90 degree

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.
Special Storage Condition, SpecifyBetween 0 and 0 *Store infusion sets in a cool, dry location at room temperature. Do not store infusion sets in direct sunlight. Do not store infusion sets where it is humid.

Device Identifiers

Device Issuing AgencyDevice ID
GS105705244021785 [Primary]
GS105705244021792 [Package]
Contains: 05705244021785
Package: Outer box [80 Units]
In Commercial Distribution
GS105705244021808 [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 Date2020-06-23
Device Publish Date2019-05-06

On-Brand Devices [Mio Advance]

05705244016514Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016484Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016453Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016422Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016392Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016361Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016330Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016309Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016279Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244016248Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
05705244016217Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
00570524416187Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
00570524416156Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
05705244021884Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244021853Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244021822Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244021792Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244021761Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244021730Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
05705244021709Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244019096Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244019065Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244018945Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244018914Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244018884Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
05705244025189Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
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