PREVENA RESTOR AXIO•FORM™

GUDID 00849554007949

PREVENA RESTOR AXIO•FORM™ DRESSING – 29CM X 28CM

KCI USA, INC.

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

• Primary Device ID: 00849554007949
• NIH Device Record Key: 4b2811ec-dd96-482d-917e-5e0b4372235d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVENA RESTOR AXIO•FORM™
• Version Model Number: PRE5555
• 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: 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	00849554007833 [Primary]
GS1	00849554007949 [Package]; Contains: 00849554007833; Package: 5-pack [5 Units]; In Commercial Distribution
GS1	00849554007956 [Package]; Package: 1-pack [1 Units]; In Commercial Distribution

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-27
• Device Publish Date: 2019-12-19

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

• 00849554007949: PREVENA RESTOR AXIO•FORM™ DRESSING – 29CM X 28CM
• 00849554007826: PREVENA RESTOR AXIO•FORM™ DRESSING- 29CM X 28CM SYSTEM KIT