PREVENA RESTOR™ BELLA•FORM™

GUDID 00849554007178

PREVENA RESTOR™ BELLA•FORM™ 24CM X 22CM SYSTEM KIT

KCI USA, INC.

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

• Primary Device ID: 00849554007178
• NIH Device Record Key: abaddf2e-f0d7-44bc-8ef2-5295942e2645
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVENA RESTOR™ BELLA•FORM™
• Version Model Number: PRE5355
• 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: true
• 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	00849554007178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181507

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: 2019-10-14
• Device Publish Date: 2019-04-23

On-Brand Devices [PREVENA RESTOR™ BELLA•FORM™]

• 00849554007147: PREVENA RESTOR™ BELLA•FORM™ DRESSING – 29CM X 27CM
• 00849554007123: PREVENA RESTOR™ BELLA•FORM™ DRESSING – 24CM X 22CM
• 00849554007161: PREVENA RESTOR™ BELLA•FORM™ DRESSING – 21CM X 19CM
• 00849554007178: PREVENA RESTOR™ BELLA•FORM™ 24CM X 22CM SYSTEM KIT
• 00849554007154: PREVENA RESTOR™ BELLA•FORM™ 21CM X 19CM SYSTEM KIT
• 00849554007130: PREVENA RESTOR™ BELLA•FORM™ 29CM X 27CM SYSTEM KIT