C7-XR™ 15211-01

GUDID 00812059021536

Software Upgrade Kit

LIGHTLAB IMAGING, INC.

Coronary optical coherence tomography system

• Primary Device ID: 00812059021536
• NIH Device Record Key: fb6bc945-02b7-4442-913e-2af0a5b7f94e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C7-XR™
• Version Model Number: C.0.4 Software Upgrade
• Catalog Number: 15211-01
• 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. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812059021536 [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: 2016-03-18

Devices Manufactured by LIGHTLAB IMAGING, INC.

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• 05415067030856 - AptiVue™: 2020-11-03 Software Upgrade Kit
• 00183739000678 - ILUMIEN™: 2019-02-11 Imaging System
• 00183739000937 - OPTIS™: 2019-02-11 Imaging System
• 00812059021420 - OPTIS™: 2019-02-11 Imaging System
• 00183739000562 - C7 Dragonfly™: 2018-03-29 Imaging Catheter
• 00183739000623 - Dragonfly™: 2018-03-29 Imaging Catheter