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 ID00849554007949
NIH Device Record Key4b2811ec-dd96-482d-917e-5e0b4372235d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREVENA RESTOR AXIO•FORM™
Version Model NumberPRE5555
Company DUNS102726734
Company NameKCI USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849554007833 [Primary]
GS100849554007949 [Package]
Contains: 00849554007833
Package: 5-pack [5 Units]
In Commercial Distribution
GS100849554007956 [Package]
Package: 1-pack [1 Units]
In Commercial Distribution

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 Date2019-12-27
Device Publish Date2019-12-19

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

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

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