Visby Medical Sexual Health Test PS-300681

GUDID 10810031720061

Visby Medical, Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical

• Primary Device ID: 10810031720061
• NIH Device Record Key: 017c1d2e-363c-4dbc-b5f5-8baef75efead
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visby Medical Sexual Health Test
• Version Model Number: PS-001402
• Catalog Number: PS-300681
• Company DUNS: 933894748
• Company Name: Visby Medical, Inc.
• 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: true
• Expiration Date: true
• 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	00810031720064 [Primary]
GS1	10810031720061 [Package]; Contains: 00810031720064; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200748

FDA Product Code

• LSL: Dna-Reagents, Neisseria

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: 2023-04-27
• Device Publish Date: 2023-04-19

Devices Manufactured by Visby Medical, Inc.

• 10810031720061 - Visby Medical Sexual Health Test: 2023-04-27
• 10810031720061 - Visby Medical Sexual Health Test: 2023-04-27
• 00810031720071 - Visby Medical Power Adapter, Right Angle: 2023-04-27
• 00810031720002 - Visby Medical Sexual Health Click Test: 2021-09-23 Visby Medical Sexual Health Click Test
• 00810031720033 - Visby Medical Power Adapter: 2021-09-23 Visby Medical Power Adapter.
• 00810031720057 - Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack: 2021-09-23 Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.