VERSA NPWT System

GUDID 00851675007401

VERSA Negative Pressure Wound Therapy powered suction pump

CORK MEDICAL, LLC

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00851675007401
• NIH Device Record Key: ae0ea3bb-88c0-4608-a62b-fdcbdea9b050
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERSA NPWT System
• Version Model Number: VCMPP-100
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00851675007401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241061

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: 2025-05-23
• Device Publish Date: 2025-05-15

Devices Manufactured by CORK MEDICAL, LLC

• 00851675007395 - 100ml Canister: 2025-05-23 VERSA 100ml Canister
• 00851675007401 - VERSA NPWT System: 2025-05-23VERSA Negative Pressure Wound Therapy powered suction pump
• 00851675007401 - VERSA NPWT System: 2025-05-23 VERSA Negative Pressure Wound Therapy powered suction pump
• 00851675007005 - Nisus NPWT System: 2018-07-06 Negative Pressure Wound Therapy System (battery charger, user manual and patient bag included)
• 00851675007012 - Nisus NPWT Wound Kit: 2018-07-06 Negative Pressure Wound Therapy Dressing, Wound Kit, Medium with 1.2.3 Drape
• 00851675007029 - Nisus NPWT Wound Kit: 2018-07-06 Negative Pressure Wound Therapy Dressing, Wound Kit, Large with 1.2.3 Drape
• 00851675007036 - Nisus NPWT Accessory: 2018-07-06 NPWT 10" x 12" 1.2.3 Drape
• 00851675007043 - Nisus NPWT Accessory: 2018-07-06 NPWT, Peel and Stick Drape
• 00851675007050 - Nisus NPWT Accessory: 2018-07-06 NPWT, Medium Foam