Pylo Health

GUDID 00860011521204

Pylo Blood Glucose Meter Device GL1-LTE

Prevounce Health, Inc

Blood glucose/blood pressure monitoring system, home-use

• Primary Device ID: 00860011521204
• NIH Device Record Key: 28e122fc-02c2-42c2-8d00-2ee8f9f52c93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pylo Health
• Version Model Number: GL1-LTE
• Company DUNS: 116961530
• Company Name: Prevounce Health, 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: 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	00860011521204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223722

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2024-04-23
• Device Publish Date: 2024-04-15

On-Brand Devices [Pylo Health]

• 00860004709596: Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor.
• 00860011521259: Blood Glucose Monitoring System Kit
• 00860011521242: Pylo single use lancets
• 00860011521235: Pylo Lancing Device
• 00860011521228: Pylo Blood Glucose Test Strip
• 00860011521211: Pylo Control Solution
• 00860011521204: Pylo Blood Glucose Meter Device GL1-LTE
• 00860011521266: LTE connected spot measurement pulse oximeter