Nisus NPWT Accessory

GUDID 00851675007128

Y-Connector

CORK MEDICAL, LLC

Negative-pressure wound therapy system dressing set

• Primary Device ID: 00851675007128
• NIH Device Record Key: a4b0b328-8ea1-4ae0-b213-5e3776ad8a35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nisus NPWT Accessory
• Version Model Number: CWY-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: true
• 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	00851675007128 [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: 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 Accessory]

• 00851675007128: Y-Connector
• 00851675007081: 24" Tubing Extension
• 00851675007074: Port Pad Assembly
• 00851675007067: Large Foam
• 00851675007050: NPWT, Medium Foam
• 00851675007043: NPWT, Peel and Stick Drape
• 00851675007036: NPWT 10" x 12" 1.2.3 Drape