PREVENA PLUS™

GUDID 00849554007819

PREVENA PLUS™ 125 THERAPY UNIT (14-DAY) WITH PREVENA PLUS™ 150ML CANISTER

KCI USA, INC.

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

• Primary Device ID: 00849554007819
• NIH Device Record Key: 15210931-6d5d-4047-b904-bd6ff7f6d342
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVENA PLUS™
• Version Model Number: PRE4010
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00849554007819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180855

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: 2
• Public Version Date: 2019-12-18
• Device Publish Date: 2019-11-28

On-Brand Devices [PREVENA PLUS™]

• 00849554006768: Prevena Plus 125 Therapy Unit Prevena Plus 125 Therapy Unit with Prevena Plus 150ml Canister
• 00849554005358: Prevena Plus Incision Management System
• 00849554005310: Prevena Plus 150 ml Canister
• 00849554007819: PREVENA PLUS™ 125 THERAPY UNIT (14-DAY) WITH PREVENA PLUS™ 150ML CANISTER