Durma+ Large Foam Dressing Kit, Large, 10" x 5.9" Foam

GUDID 00840117342316

Sterile-R, Sterile-EO, Content: 1- Foam, Large, 10" x 5.9", 1- Suction Bell with Tubing, 1- Transparent Wound Drape

Dynarex Corporation

Irrigation negative-pressure wound therapy dressing

• Primary Device ID: 00840117342316
• NIH Device Record Key: ee7b0fe2-aba6-4dd3-ac1b-2f4162b750e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durma+ Large Foam Dressing Kit, Large, 10" x 5.9" Foam
• Version Model Number: 3125
• 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	00840117342286 [Package]; Package: Case [10 Units]; In Commercial Distribution
GS1	00840117342316 [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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