3M™ Prevena Restor™ Adaptiform™ PRE6001

GUDID 00849554008014

3M™ Prevena Restor™ Adaptiform™ System Kit

KCI USA, INC.

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: 00849554008014
• NIH Device Record Key: 706d3092-c5a2-4f58-b1a5-80aebf20c3c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3M™ Prevena Restor™ Adaptiform™
• Version Model Number: PRE6001
• Catalog Number: PRE6001
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849554008014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220660

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: 2022-08-26
• Device Publish Date: 2022-08-18

On-Brand Devices [3M™ Prevena Restor™ Adaptiform™]

• 00849554008373: 3M™ Prevena Restor™ Adaptiform™ Dressing 5-pack
• 00849554008014: 3M™ Prevena Restor™ Adaptiform™ System Kit