ILUMIEN™ C408650

GUDID 00183739000678

Imaging System

LIGHTLAB IMAGING, INC.

Coronary optical coherence tomography system
Primary Device ID00183739000678
NIH Device Record Key1171e52d-c4bb-4f49-8d87-0b6dedaa6193
Commercial Distribution StatusIn Commercial Distribution
Brand NameILUMIEN™
Version Model NumberOPTIS™
Catalog NumberC408650
Company DUNS018493531
Company NameLIGHTLAB IMAGING, 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

Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100183739000678 [Primary]

FDA Product Code

NQQSYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-11
Device Publish Date2016-03-23

On-Brand Devices [ILUMIEN™]

00812059021482Software Upgrade Kit
00812059021383Software Upgrade Kit
00812059021338D.2 Software
00812059020560Software Upgrade Kit
00183739000678Imaging System
00183739000630Imaging System

Trademark Results [ILUMIEN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ILUMIEN
ILUMIEN
86060607 4577532 Live/Registered
LightLab Imaging, Inc.
2013-09-10
ILUMIEN
ILUMIEN
85318236 4258470 Live/Registered
LightLab Imaging, Inc.
2011-05-11

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