iFusion 700-49002-005

GUDID 00858848006643

iVue NR for iFusion 230V

OPTOVUE, INC.

Spectral-domain optical coherence tomography system
Primary Device ID00858848006643
NIH Device Record Keyd4f2daff-146b-4c6f-b743-3bebf60b6207
Commercial Distribution StatusIn Commercial Distribution
Brand NameiFusion
Version Model NumberiFusion
Catalog Number700-49002-005
Company DUNS196500461
Company NameOPTOVUE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-941-9240
Emailservice@optovue.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858848006643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKICamera, Ophthalmic, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-21
Device Publish Date2019-01-21

On-Brand Devices [iFusion]

00858848006650iVue NR for iFusion USCFG 230V
00858848006643iVue NR for iFusion 230V
00858848006636iVue NR for iFusion USCFG 120V
00858848006629iVue NR for iFusion 120V
00858848006308iVue NR for iFusion USCFG System w/ 230V Table
00858848006292iVue NR for iFusion System w/ 230V Table
00858848006247iVue NR for iFusion USCFG System w/ 120V Table
00858848006230iVue NR for iFusion System w/ 120V Table
00858848006209iVue NR for iFusion USCFG 230V
00858848006193iVue NR for iFusion 230V
00858848006186iVue NR for iFusion USCFG 120V
00858848006179iVue NR for iFusion 120V
00858848006766iFusion 80 with 12 MP Camera

Trademark Results [iFusion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IFUSION
IFUSION
86007047 4625856 Live/Registered
Optovue, Inc.
2013-07-10
IFUSION
IFUSION
85246152 4028473 Dead/Cancelled
Altigen Communications, Inc.
2011-02-18
IFUSION
IFUSION
78857084 not registered Dead/Abandoned
GENTEC
2006-04-07
IFUSION
IFUSION
76074827 not registered Dead/Abandoned
Waller, Stephen Mark
2000-06-20
IFUSION
IFUSION
75934604 2700808 Dead/Cancelled
iFusion, LLC
2000-03-03

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