Neria Guard

GUDID 05705244022331

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: 05705244022331
• NIH Device Record Key: be026143-0573-4dec-8d90-e1bae554967e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neria Guard
• Version Model Number: 704110-5226
• 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: false
• 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
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Device Dimensions

• Angle: 90 degree
• Length: 110 Centimeter
• Depth: 6 Millimeter
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• Length: 110 Centimeter
• Depth: 6 Millimeter
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• Length: 110 Centimeter
• Depth: 6 Millimeter
• Angle: 90 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	05705244022324 [Primary]
GS1	05705244022331 [Package]; Contains: 05705244022324; Package: Outer box [80 Units]; In Commercial Distribution
GS1	05705244022348 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192647

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-01-24

On-Brand Devices [Neria Guard]

• 05705244022362: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022331: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022300: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022270: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022249: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022218: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022188: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022157: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022126: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022096: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022065: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022034: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244022003: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i
• 05705244021976: Single use infusion set for subcutaneous infusion. The infusion set must be used as described i