Ilumien™ C408660

GUDID 00812059021338

LIGHTLAB IMAGING, INC.

Coronary optical coherence tomography system

• Primary Device ID: 00812059021338
• NIH Device Record Key: 93d536e5-2459-4c57-b0d6-ac0483049824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ilumien™
• Version Model Number: D.2 Software
• Catalog Number: C408660
• 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: true
• Serial Number: false
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812059021338 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-05-27

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