V.A.C.ULTA™

GUDID 00849554000636

VAC ULTA THERAPY SYSTEM

KCI USA, INC.

Irrigation negative-pressure wound therapy unit
Primary Device ID00849554000636
NIH Device Record Key7ad85630-d6d0-4e9f-9bb2-4eccc89c80da
Commercial Distribution StatusIn Commercial Distribution
Brand NameV.A.C.ULTA™
Version Model NumberULTDEV01/US
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 Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849554000636 [Primary]
GS100849554001244 [Direct Marking]

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 Number4
Public Version Date2018-08-22
Device Publish Date2016-09-24

On-Brand Devices [V.A.C.ULTA™]

00849554006775Solution Container Hanger Arm Extension
00849554001244VAC ULTA THERAPY SYSTEM
00849554000636VAC ULTA THERAPY SYSTEM

Trademark Results [V.A.C.ULTA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
V.A.C.ULTA
V.A.C.ULTA
77846714 4071104 Live/Registered
KCI Licensing, Inc.
2009-10-12

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