prolaio Mobile App

GUDID 00850071330007

prolaio medical device data system mobile application

Prolaio, Inc.

Electrocardiography monitoring system receiver

• Primary Device ID: 00850071330007
• NIH Device Record Key: d26d97c2-b9c2-473b-976e-2b4ee8877d3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: prolaio Mobile App
• Version Model Number: DP-22-06
• Company DUNS: 118827870
• Company Name: Prolaio, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850071330007 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2025-06-23
• Device Publish Date: 2025-06-13

Devices Manufactured by Prolaio, Inc.

• 00850071330007 - prolaio Mobile App: 2025-06-23prolaio medical device data system mobile application
• 00850071330007 - prolaio Mobile App: 2025-06-23 prolaio medical device data system mobile application
• 00850071330014 - prolaio Cloud: 2025-06-23 prolaio medical device data system cloud
• 00850071330038 - prolaio Personalized Physiology Analytics Engine Software (PPA): 2025-06-23 prolaio Personalized Physiology Analytics Engine Software
• 00850071330045 - prolaio Heart Rhythm and Respiration Module: 2025-06-23 prolaio Heart Rhythm and Respiration Module
• 00850071330069 - prolaio Convenience Kit: 2025-06-23 prolaio Convenience Kit - Model D
• 00850071330076 - prolaio Convenience Kit: 2025-06-23 prolaio Convenience Kit - Model C
• 00850071330083 - prolaio Convenience Kit: 2025-06-23 prolaio Convenience Kit - Model F
• 00850071330090 - prolaio Convenience Kit: 2025-06-23 prolaio Convenience Kit - Model B