Pylo Health

GUDID 00860011521211

Pylo Control Solution

Prevounce Health, Inc

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• Primary Device ID: 00860011521211
• NIH Device Record Key: 83170bcf-8916-45ad-a9fa-a170e5b31581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pylo Health
• Version Model Number: GL1-CTR
• Company DUNS: 116961530
• Company Name: Prevounce Health, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00860011521211 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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