PatientCare Platform

GUDID 00852132007286

Platform software application for data collection and analysis

PREVENTICE TECHNOLOGIES, INC.

Electrocardiography telemetric monitoring system
Primary Device ID00852132007286
NIH Device Record Keyf5e797b3-76dc-43de-953a-4a578b73c1a3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatientCare Platform
Version Model NumberSW1001
Company DUNS859807815
Company NamePREVENTICE TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852132007286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDetector And Alarm, Arrhythmia
NSXSoftware, Transmission And Storage, Patient Data

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-24
Device Publish Date2021-06-16

Devices Manufactured by PREVENTICE TECHNOLOGIES, INC.

00852132007255 - BodyGuardian2022-04-05 Mini Short Slide Strip - Hydrocolloid
00852132007187 - BodyGuardian2022-04-04 Mini Short Slide Strip - Acrylic
00852132007231 - BodyGuardian Mini Short Slide Strip2021-09-23 Mini Short Slide Strip - Acrylic
00852132007194 - BodyGuardian Mini Short Slide Strip2021-07-08 Mini Short Slide Strip - Silicone
00852132007200 - BodyGuardian2021-06-24 BodyGuardian Mini Procedure Pack
00852132007217 - BodyGuardian Mini Monitoring System Kit2021-06-24 BodyGuardian Mini Monitoring System Kit - holter for FBS customers
00852132007224 - BodyGuardian Mini Plus Monitoring System Kit2021-06-24 BodyGuardian Mini Plus Monitoring System Kit for FBS customers
00852132007248 - BodyGuardian One2021-06-24 BodyGuardian One FBS Remote Monitoring System

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