INSPIRA

GUDID 04961333254934

PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 90963)

HOYA CORPORATION

Endoscopic video image processing unit

• Primary Device ID: 04961333254934
• NIH Device Record Key: 7bb3a632-025b-45f5-9cc3-069aa13a111b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSPIRA
• Version Model Number: EPK-i8020c
• 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	04961333254910 [Primary]
GS1	04961333254934 [Direct Marking]

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)
• PEA: Endoscope, accessories, image post-processing for color enhancement

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: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [INSPIRA]

• 04961333247929: PENTAX Medical Video Processor EPK-i8020c
• 04961333251896: PENTAX Medical Video Colonoscope EC38-i20cL
• 04961333251858: PENTAX Medical Video Upper GI Scope EG29-i20c
• 04961333254934: PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 90963)