VitalScan HRV

GUDID 08690020003031

Medeia, Inc.

Pulse Co-oximeter probe, reusable

• Primary Device ID: 08690020003031
• NIH Device Record Key: 3d71589c-2663-4a22-ac2d-7ee9b805fc16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalScan HRV
• Version Model Number: HW6
• Company DUNS: 031827187
• Company Name: Medeia, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08690020003031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083735

FDA Product Code

• DPS: Electrocardiograph

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: 2025-02-13
• Device Publish Date: 2025-02-05

Devices Manufactured by Medeia, Inc.

• 08690020003017 - VitalScan ANS: 2025-02-13
• 08690020003024 - SudoCheck: 2025-02-13
• 08690020003031 - VitalScan HRV: 2025-02-13
• 08690020003031 - VitalScan HRV: 2025-02-13
• 08690020003062 - BrainView NeuralScan: 2025-02-13