PREVENA PLUS™ CUSTOMIZABLE™

GUDID 00849554005303

Prevena Plus Customizable Dressing with Sensatrac Technology

KCI USA, INC.

Negative-pressure wound therapy system, battery-powered, single-use

• Primary Device ID: 00849554005303
• NIH Device Record Key: 968556c6-242f-4c8e-92b6-f8a41ccc82c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVENA PLUS™ CUSTOMIZABLE™
• Version Model Number: Prevena Plus Customizable Dressing
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00849554005303 [Primary]
GS1	00849554005334 [Package]; Package: 5 PACK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153199

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: 5
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by KCI USA, INC.

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