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

• 04961333254620 - PENTAX Medical: 2024-12-23 PENTAX Medical R/L Assistant Knob OE-B17
• 04961333356393 - PENTAX Medical: 2024-12-23 PENTAX Medical Video Upper GI Scope EG27-i20c
• 04961333356416 - PENTAX Medical: 2024-12-23 PENTAX Medical Video Colonoscope EC34-i20cL
• 04961333356331 - PENTAX Medical: 2024-09-11 PENTAX Medical Video Duodenoscope ED34-i10T2s
• 04961333254781 - PENTAX: 2024-08-05 PENTAX VIDEO COLONOSCOPE EC-2990i SERIES
• 04961333254460 - PENTAX: 2024-08-05 PENTAX VIDEO COLONOSCOPE EC34-i10 SERIES
• 04961333254811 - PENTAX: 2024-08-05 PENTAX VIDEO COLONOSCOPE EC-3890TK SERIES
• 04961333254477 - PENTAX: 2024-08-05 PENTAX VIDEO COLONOSCOPE EC38-i10 SERIES