VIVIDEO

GUDID 04961333221103

HOYA CORPORATION

Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit Endoscopic video image processing unit

• Primary Device ID: 04961333221103
• NIH Device Record Key: 00341dbf-60b8-409a-a499-7de8b29008bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVIDEO
• Version Model Number: CP-1000
• Company DUNS: 691519705
• Company Name: HOYA 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333221103 [Direct Marking]
GS1	04961333239825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171011

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-15
• Device Publish Date: 2024-02-07

Devices Manufactured by HOYA CORPORATION

• 04961333251025 - PENTAX Medical: 2024-03-19 PENTAX Water Bottle Assembly
• 04961333221103 - VIVIDEO: 2024-02-15
• 04961333221103 - VIVIDEO: 2024-02-15
• 04961333252121 - PENTAX Medical: 2023-12-21 PENTAX Medical Gas/Water Feeding Valve OE-B14
• 04961333254934 - INSPIRA: 2023-12-11 PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 90963)
• 04961333249176 - DEFINA: 2023-11-08 PENTAX Medical Video Processor EPK-3000
• 04961333251650 - PENTAX Medical: 2023-11-08 PENTAX Medical Keyboard EN OS-A116
• 04961333251827 - PENTAX Medical: 2023-09-28 PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15
• 04961333251834 - PENTAX Medical: 2023-09-28 PENTAX Medical Cylinder Cleaning Adapter OE-B16