ILUMIEN™ C408650

GUDID 00183739000678

Imaging System

LIGHTLAB IMAGING, INC.

Coronary optical coherence tomography system

• Primary Device ID: 00183739000678
• NIH Device Record Key: 1171e52d-c4bb-4f49-8d87-0b6dedaa6193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ILUMIEN™
• Version Model Number: OPTIS™
• Catalog Number: C408650
• Company DUNS: 018493531
• Company Name: LIGHTLAB IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00183739000678 [Primary]

FDA Product Code

• NQQ: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-11
• Device Publish Date: 2016-03-23

On-Brand Devices [ILUMIEN™]

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