inset™ N/A

GUDID 05705244025219

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: 05705244025219
• NIH Device Record Key: d24ab88d-df72-4ed6-bff3-ae0745d23ed8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inset™
• Version Model Number: FG000016-01
• Catalog Number: N/A
• Company DUNS: 306032491
• Company Name: Unomedical A/S
• Device Count: 10
• 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.
• Special Storage Condition, Specify: Between 0 and 0 *Store inset™ in a cool, dry location at room temperature. Do not store inset™ in direct sunlight, or in high humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05705244025202 [Primary]
GS1	05705244025219 [Package]; Contains: 05705244025202; Package: Outer box [100 Units]; In Commercial Distribution
GS1	05705244025226 [Unit of Use]

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: 2021-10-27
• Device Publish Date: 2021-10-19

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• 05705244006959: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006942: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006935: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006928: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006911: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006898: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006881: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006874: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006867: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006843: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244006836: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244004825: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244004801: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244022393: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244025240: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244025219: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244026292: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in
• 05705244026261: Single use infusion set for subcutaneous infusion. The infusion set must be used as described in