Pylo Health

GUDID 00860004709503

Cellular connected (Cat-M) non-invasive blood pressure monitor.

PREVOUNCE HEALTH, LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00860004709503
• NIH Device Record Key: 8bf394c6-2582-452e-bd96-054df41dc36d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pylo Health
• Version Model Number: PY-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: 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	00860004709503 [Primary]
GS1	10860004709500 [Package]; Package: Carton [10 Units]; In Commercial Distribution

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: 2020-09-09
• Device Publish Date: 2020-09-01

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.