LensHooke Semen Test Cassette

GUDID 14719874741157

BONRAYBIO CO., LTD.

Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD Microscope counting chamber IVD

• Primary Device ID: 14719874741157
• NIH Device Record Key: ac426b89-4429-4b83-8392-efce9808fca2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LensHooke Semen Test Cassette
• Version Model Number: CS1_US-HT
• Company DUNS: 658872369
• Company Name: BONRAYBIO CO., LTD.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	14719874741157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202089

FDA Product Code

• POV: Semen Analysis Device

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: 2021-01-21
• Device Publish Date: 2021-01-13

On-Brand Devices [LensHooke Semen Test Cassette]

• 14719874741157: CS1_US-HT
• 14719874741140: CS1_US-BR USA
• 54719874741155: CS1_400pcs_HT
• 54719874741148: CS1_400pcs_BR USA CORP.
• 54719874740769: CS0_400pcs_BR USA CORP.
• 54719874740714: CS0_400pcs
• 44719874741158: CS1_200pcs_HT
• 44719874741141: CS1_200pcs_BR USA CORP.
• 44719874740762: CS0_200pcs_BR USA CORP.
• 44719874740717: CS0_200pcs