Nisus NPWT Wound Kit

GUDID 00851675007203

Negative Pressure Wound Therapy Dressing, Wound Kit,FM-1.25-5-8-A-16 Thick Foam

CORK MEDICAL, LLC

Negative-pressure wound therapy system dressing set

• Primary Device ID: 00851675007203
• NIH Device Record Key: 85dedd79-4ac9-4639-9482-6824bd58c159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nisus NPWT Wound Kit
• Version Model Number: FM-1.25-5-8-A-16
• Company DUNS: 015964214
• Company Name: CORK MEDICAL, LLC
• 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: false
• 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	00851675007203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132004

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-09

On-Brand Devices [Nisus NPWT Wound Kit]

• 00851675007227: Negative Pressure Wound Therapy Dressing, Wound Kit, WDK-250 Wound Kit, Small with 1.2.3. Drape
• 00851675007210: Negative Pressure Wound Therapy Dressing, Wound Kit, WDK300T Wound Kit, Thick Foam with 1.2.3. D
• 00851675007203: Negative Pressure Wound Therapy Dressing, Wound Kit,FM-1.25-5-8-A-16 Thick Foam
• 00851675007029: Negative Pressure Wound Therapy Dressing, Wound Kit, Large with 1.2.3 Drape
• 00851675007012: Negative Pressure Wound Therapy Dressing, Wound Kit, Medium with 1.2.3 Drape