Nisus NPWT System

GUDID 00851675007135

Nisus Charger

CORK MEDICAL, LLC

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00851675007135
• NIH Device Record Key: aec2765e-d31a-4560-8dc5-f6b5d43ec25c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nisus NPWT System
• Version Model Number: NIS-CHRG-B-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: false
• Lot Batch: true
• Serial Number: false
• 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	00851675007135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140022

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-02

On-Brand Devices [Nisus NPWT System]

• 00851675007135: Nisus Charger
• 00851675007104: 500 mL Canister
• 00851675007098: 250-mL Canister
• 00851675007005: Negative Pressure Wound Therapy System (battery charger, user manual and patient bag included)