Visby Medical Sexual Health Test PS-300681

GUDID 10810031720061

Visby Medical, Inc.

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.