3M™ Prevena Restor™ Adaptiform™ PRE6055

GUDID 00849554008373

3M™ Prevena Restor™ Adaptiform™ Dressing 5-pack

KCI USA, INC.

Negative-pressure wound therapy system foam dressing, non-antimicrobial
Primary Device ID00849554008373
NIH Device Record Key7fd28e51-9dae-4641-a534-23792b4c6df9
Commercial Distribution StatusIn Commercial Distribution
Brand Name3M™ Prevena Restor™ Adaptiform™
Version Model NumberPRE6055
Catalog NumberPRE6055
Company DUNS102726734
Company NameKCI USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com
Phone+1(800)228-3957
Email3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849554008373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPnegative pressure wound therapy Powered suction pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-26
Device Publish Date2022-08-18

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

008495540083733M™ Prevena Restor™ Adaptiform™ Dressing 5-pack
008495540080143M™ Prevena Restor™ Adaptiform™ System Kit

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