Pleura-Guard

GUDID 05708265005703

Pleura-Guard - Anchoring device for thoracic drainage catheters from 16-30 french.

Lina Medical ApS

Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder

• Primary Device ID: 05708265005703
• NIH Device Record Key: aea2017a-4210-444b-86af-822befee6d3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pleura-Guard
• Version Model Number: 8161
• Company DUNS: 305088619
• Company Name: Lina Medical ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05708265005109 [Primary]
GS1	05708265005703 [Package]; Contains: 05708265005109; Package: box [25 Units]; In Commercial Distribution
GS1	05708265008858 [Package]; Package: box [6 Units]; In Commercial Distribution

FDA Product Code

• KGZ: Accessories, Catheter

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: 2023-06-15
• Device Publish Date: 2023-06-07

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• 05708265005703 - Pleura-Guard: 2023-06-15Pleura-Guard - Anchoring device for thoracic drainage catheters from 16-30 french.
• 05708265005703 - Pleura-Guard: 2023-06-15 Pleura-Guard - Anchoring device for thoracic drainage catheters from 16-30 french.
• 05708265005932 - LiNA PowerBlade™: 2023-06-15 LiNA PowerBlade, Bipolar cutting & coagulation forceps, straight jaws, Ø 10mm, 330 mm working length, 3m cable, EURO connector