Durma+ Medium Foam Dressing Kit, Medium, 7" x 4.7" Foam

GUDID 00840117342309

Sterile-R, Sterile-EO: Contents: 1- Foam, Medium, 7" x 4.7" , 1- Suction Bell with Tubing, 1- Transparent Wound Drape

Dynarex Corporation

Irrigation negative-pressure wound therapy dressing

• Primary Device ID: 00840117342309
• NIH Device Record Key: 898a0ebe-37e0-43d3-b1cd-cdfe8d71f69d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durma+ Medium Foam Dressing Kit, Medium, 7" x 4.7" Foam
• Version Model Number: 3124
• 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: true
• 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	00840117342279 [Package]; Package: Case [10 Units]; In Commercial Distribution
GS1	00840117342309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182458

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

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: 2025-06-11
• Device Publish Date: 2025-06-03

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