TOTOKU

GUDID 04996005102923

JVC KENWOOD CORPORATION

Image display monitor, colour

• Primary Device ID: 04996005102923
• NIH Device Record Key: 68ce9b9d-a0cb-4b0f-8184-d9d5126a94cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOTOKU
• Version Model Number: CCL358i2/AR
• Company DUNS: 713321040
• Company Name: JVC KENWOOD CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04996005102923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133185

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [TOTOKU]

• 04996005103562: CCL214
• 04996005103555: CCL550i2/N
• 04996005103531: CCL550i2/F
• 04996005103524: CCL550i2/AR
• 04996005103463: CCL244/AR
• 04996005103456: CCL220/AR
• 04996005103449: CCL210
• 04996005103432: ME205
• 04996005103128: CCL650i2/AR
• 04996005103111: CCL650i2/N
• 04996005103067: MS25i2/F
• 04996005103050: MS25i2/AR
• 04996005103043: MS25i2/N
• 04996005103036: MS35i2/F
• 04996005103029: MS35i2/AR
• 04996005103012: MS35i2/N
• 04996005102961: CCL258i2/F
• 04996005102954: CCL258i2/AR
• 04996005102947: CCL258i2/N
• 04996005102930: CCL358i2/F
• 04996005102923: CCL358i2/AR
• 04996005102916: CCL358i2/N
• 04996005102909: MS55i2/F
• 04996005102893: MS55i2/AR
• 04996005102886: MS55i2/N