INFOV.A.C.™

GUDID 00849554006799

Infovac Therapy System

KCI USA, INC.

Negative-pressure wound therapy system pump, electric
Primary Device ID00849554006799
NIH Device Record Keya232192e-9e35-4c27-a88d-e6f823f338a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFOV.A.C.™
Version Model NumberM8259999
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
GS100849554001534 [Primary]
GS100849554006799 [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 Date2018-08-20
Device Publish Date2016-09-05

On-Brand Devices [INFOV.A.C.™ ]

00878237000915500 ml Canister (without Gel) for Infovac and VAC Ulta Therapy Systems
00878237000892500 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
00849554002081500 ml Canister (without Gel) for Infovac and VAC Ulta Therapy Systems
00849554002074500 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
008495540020671000 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
00849554006799Infovac Therapy System

Trademark Results [INFOV.A.C.]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INFOV.A.C.
INFOV.A.C.
78863340 3345980 Live/Registered
KCI Licensing, Inc.
2006-04-18

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