Pylo Health

GUDID 20860004709507

Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor.

PREVOUNCE HEALTH, LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 20860004709507
• NIH Device Record Key: c6e5b6b6-617d-4c00-9c8e-020a99083c5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pylo Health
• Version Model Number: 802-LTE
• Company DUNS: 116961530
• Company Name: PREVOUNCE HEALTH, LLC
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00860004709565 [Primary]
GS1	20860004709507 [Package]; Contains: 00860004709565; Package: carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202891

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2022-07-06
• Device Publish Date: 2022-06-28

On-Brand Devices [Pylo Health]

• 00860004709503: Cellular connected (Cat-M) non-invasive blood pressure monitor.
• 10860004709517: Cellular connected (LTE) body weight scale for remote patient monitoring.
• 10860004709524: Non-invasive digital blood pressure monitor.
• 10860004709531: Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor.
• 20860004709507: Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor.
• 00860004709572: Cellular connected (LTE) body weight scale for remote patient monitoring.