PatientCare Platform

GUDID 00852132007286

Platform software application for data collection and analysis

PREVENTICE TECHNOLOGIES, INC.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00852132007286
• NIH Device Record Key: f5e797b3-76dc-43de-953a-4a578b73c1a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PatientCare Platform
• Version Model Number: SW1001
• Company DUNS: 859807815
• Company Name: PREVENTICE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852132007286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192732

FDA Product Code

• DSI: Detector And Alarm, Arrhythmia
• NSX: Software, Transmission And Storage, Patient Data

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: 2021-06-24
• Device Publish Date: 2021-06-16

Devices Manufactured by PREVENTICE TECHNOLOGIES, INC.

• 00852132007255 - BodyGuardian: 2022-04-05 Mini Short Slide Strip - Hydrocolloid
• 00852132007187 - BodyGuardian: 2022-04-04 Mini Short Slide Strip - Acrylic
• 00852132007231 - BodyGuardian Mini Short Slide Strip: 2021-09-23 Mini Short Slide Strip - Acrylic
• 00852132007194 - BodyGuardian Mini Short Slide Strip: 2021-07-08 Mini Short Slide Strip - Silicone
• 00852132007200 - BodyGuardian: 2021-06-24 BodyGuardian Mini Procedure Pack
• 00852132007217 - BodyGuardian Mini Monitoring System Kit: 2021-06-24 BodyGuardian Mini Monitoring System Kit - holter for FBS customers
• 00852132007224 - BodyGuardian Mini Plus Monitoring System Kit: 2021-06-24 BodyGuardian Mini Plus Monitoring System Kit for FBS customers
• 00852132007248 - BodyGuardian One: 2021-06-24 BodyGuardian One FBS Remote Monitoring System