PREVENA RESTOR ROTO•FORM™ PRE5655

GUDID 00849554007864

PREVENA RESTOR ROTO•FORM™ DRESSING-29CM X 31CM

KCI USA, INC.

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

• Primary Device ID: 00849554007864
• NIH Device Record Key: f5bf42c0-5668-470f-b860-b54363f358d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREVENA RESTOR ROTO•FORM™
• Version Model Number: PRE5655
• Catalog Number: PRE5655
• 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

Customer Support Contacts

• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849554004771 [Primary]
GS1	00849554007864 [Package]; Contains: 00849554004771; Package: [5 Units]; In Commercial Distribution

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: 2021-03-03
• Device Publish Date: 2021-02-23

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

• 50849554007852: PREVENA RESTOR ROTO•FORM™ DRESSING-29CM X 31CM SYSTEM KIT
• 00849554007864: PREVENA RESTOR ROTO•FORM™ DRESSING-29CM X 31CM