Durma+ (NPWT) Negative Pressure Wound Therapy Pump

GUDID 00840117344648

Dynarex Corporation

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00840117344648
• NIH Device Record Key: f5c673e1-880d-45d6-a33d-ba6e9ef52a10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durma+ (NPWT) Negative Pressure Wound Therapy Pump
• Version Model Number: 3150
• 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: false
• 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	00840117344631 [Package]; Package: Case [10 Units]; In Commercial Distribution
GS1	00840117344648 [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: 2025-06-17
• Device Publish Date: 2025-06-09

Devices Manufactured by Dynarex Corporation

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• 00810180845113 - Cotton Tipped Wood Applicators, Sterile: 2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 2 per Pouch
• 00810180840712 - CurPro Dermal Curettes,2 mm: 2026-03-27 Sterile-R
• 00840117347892 - Medi-Cut Safety Scalpel: 2026-03-27 Medi-Cut Safety Scalpel, Sterile, # 15
• 00810180844901 - Disposable Prep Razors: 2026-03-25 Disposable Prep Razors
• 00810180844918 - Medicine Cups 1oz: 2026-03-25
• 00810180844925 - LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal: 2026-03-25 Sterile-EO