PREVENA RESTOR™ BELLA•FORM™

GUDID 00849554007130

PREVENA RESTOR™ BELLA•FORM™ 29CM X 27CM SYSTEM KIT

KCI USA, INC.

Negative-pressure wound therapy system, battery-powered, single-use
Primary Device ID00849554007130
NIH Device Record Key12bcd52a-b8fe-4cad-bd64-0dea84b1a78b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREVENA RESTOR™ BELLA•FORM™
Version Model NumberPRE5455
Company DUNS102726734
Company NameKCI USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100849554007130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.