Durma+ Y-Type Suction Drainage Tube, 10 Fr

GUDID 00840117345539

Dynarex Corporation

Negative-pressure wound therapy system canister

• Primary Device ID: 00840117345539
• NIH Device Record Key: 9ab58262-8ab4-4dc6-ad94-c4bf1cc4780e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durma+ Y-Type Suction Drainage Tube, 10 Fr
• Version Model Number: 3147
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117345522 [Package]; Package: Case [20 Units]; In Commercial Distribution
GS1	00840117345539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162159

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

Devices Manufactured by Dynarex Corporation

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• 00616784345611 - Durma+ Unna Boot Bandage with Zinc Oxide and Calamine: 2025-12-26 Size: 4" x 10 yd. (10.2 cm x 9.1m)
• 00616784345314 - Durma+ Unna Boot Bandage with Zinc Oxide: 2025-12-25 3" x 10" yd (7.6 cm x 9.1 m)
• 00616784345437 - Durma+ Unna Boot Bandage with Zinc Oxide: 2025-12-25 4" x 10 yd (10.2 cm x 9.1m)
• 00840117345751 - Durma+ SiliGentle Silicone Foam Dressing, Bordered: 2025-12-18 4" x 8" (10,cm x 20,3 cm) , STERILE-EO
• 00840117345782 - Durma+ SiliGentle Silicone Foam Dressing, Bordered: 2025-12-18 8" x 8" (20,3 cm x 20,3 cm), STERILE-EO
• 00840117345812 - Durma+ SiliGentle Silicone Foam Dressing, Bordered: 2025-12-18 8" x 6" (20,3 cm x 15,2 cm), STERILE-EO
• 00840117345539 - Durma+ Y-Type Suction Drainage Tube, 10 Fr: 2025-12-02
• 00840117345539 - Durma+ Y-Type Suction Drainage Tube, 10 Fr: 2025-12-02