PREVENA RESTOR™ BELLA•FORM™

GUDID 00849554007123

PREVENA RESTOR™ BELLA•FORM™ DRESSING – 24CM X 22CM

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, 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 ID00849554007123
NIH Device Record Keyef5f0a77-5676-4650-b26f-c2a9930ac32a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREVENA RESTOR™ BELLA•FORM™
Version Model NumberPREVENA RESTOR™ BELLA•FORM™
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
GS100849554007123 [Package]
Contains: 00849554007475
Package: 5-PACK [5 Units]
In Commercial Distribution
GS100849554007475 [Primary]
GS100849554007901 [Package]
Contains: 00849554007475
Package: 2-PACK [2 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-14
Device Publish Date2019-04-23

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

00849554007147PREVENA RESTOR™ BELLA•FORM™ DRESSING – 29CM X 27CM
00849554007123PREVENA RESTOR™ BELLA•FORM™ DRESSING – 24CM X 22CM
00849554007161PREVENA RESTOR™ BELLA•FORM™ DRESSING – 21CM X 19CM
00849554007178PREVENA RESTOR™ BELLA•FORM™ 24CM X 22CM SYSTEM KIT
00849554007154PREVENA RESTOR™ BELLA•FORM™ 21CM X 19CM SYSTEM KIT
00849554007130PREVENA RESTOR™ BELLA•FORM™ 29CM X 27CM SYSTEM KIT

Trademark Results [PREVENA RESTOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREVENA RESTOR
PREVENA RESTOR
88099676 not registered Live/Pending
KCI LICENSING, INC.
2018-08-30

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