VIVIDEO

GUDID 04961333221103

HOYA CORPORATION

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

• 04961333255818 - INSPIRA: 2025-06-30 PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 91108)
• 04961333255832 - INSPIRA: 2025-06-30 PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 91110)
• 04961333356478 - PENTAX Medical: 2025-05-06 PENTAX Medical Video Colonoscope EC38-i20cWL
• 84961333253919 - PENTAX: 2025-04-16 PENTAX Balloon OE-A52
• 04961333129430 - PENTAX: 2025-04-14 PENTAX Video Colonoscope EC-3890Li
• 04961333172085 - PENTAX: 2025-04-14 PENTAX Video Colonoscope EC38-i10L
• 04961333129492 - PENTAX: 2025-04-14 VIDEO UPPER G.I.SCOPE EG-2990i
• 04961333211692 - PENTAX: 2025-04-14 PENTAX VIDEO UPPER G.I.SCOPE EG29-i10