Mio Advance

GUDID 05705244025189

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 ID: 05705244025189
• NIH Device Record Key: cf336962-2795-4ced-a0a9-621597e9c274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mio Advance
• Version Model Number: MMT-243AT
• 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: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
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• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
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• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx
• Phone: 9999999999
• Email: xx@xx.xx

Device Dimensions

• Angle: 90 degree
• Depth: 9 Millimeter
• Length: 60 Centimeter
• Angle: 90 degree
• Depth: 9 Millimeter
• Length: 60 Centimeter
• Angle: 90 degree
• Depth: 9 Millimeter
• Length: 60 Centimeter
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• Length: 60 Centimeter
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• Length: 60 Centimeter
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• Length: 60 Centimeter
• Angle: 90 degree
• Depth: 9 Millimeter
• Length: 60 Centimeter
• Angle: 90 degree
• Depth: 9 Millimeter
• Length: 60 Centimeter
• Angle: 90 degree
• Depth: 9 Millimeter
• Length: 60 Centimeter
• Angle: 90 degree
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• Length: 60 Centimeter
• Angle: 90 degree
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• Angle: 90 degree
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• Length: 60 Centimeter
• Angle: 90 degree
• Depth: 9 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt 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 direcrt sunlight. Do not store infusion sets where it is humid.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05705244025172 [Primary]
GS1	05705244025189 [Package]; Contains: 05705244025172; Package: Outer box [36 Units]; In Commercial Distribution
GS1	05705244025196 [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: 2021-02-11
• Device Publish Date: 2021-02-03

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