Mio Advance

GUDID 05705244019065

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	05705244019065
NIH Device Record Key	554078e8-30fd-4b8f-9590-0276da3ceb5e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Mio Advance
Version Model Number	MMT-242AT
Company DUNS	306032491
Company Name	Unomedical A/S
Device Count	2
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	true
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

Device Dimensions

Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter
Angle	90 degree
Depth	6 Millimeter
Length	60 Centimeter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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, Specify	Between 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 Agency	Device ID
GS1	05705244019058 [Primary]
GS1	05705244019065 [Package] Contains: 05705244019058 Package: Outer box [36 Units] In Commercial Distribution
GS1	05705244019072 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173879

FDA Product Code

FPA	Set, Administration, Intravascular

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-05-25
Device Publish Date	2020-05-15

On-Brand Devices [Mio Advance]

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