physIQ UI (accelerateIQ)

GUDID 00860004366232

physIQ Medical Device Data System User Interface

PHYSIQ, INC

Electrocardiography telemetric monitoring system
Primary Device ID00860004366232
NIH Device Record Key5c7398de-3b88-47b2-9a66-9847082f2578
Commercial Distribution StatusIn Commercial Distribution
Brand NamephysIQ UI (accelerateIQ)
Version Model Number4.4 (Golan)
Company DUNS079107007
Company NamePHYSIQ, INC
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 855-869-9054
Emailsupport@physIQ.com
Phone+1 855-869-9054
Emailsupport@physIQ.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004366232 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-19
Device Publish Date2020-10-10

Devices Manufactured by PHYSIQ, INC

00850023120267 - physIQ Patient Kit2022-10-04 physIQ convenience kit including biosensors, mobile hub, and skin preparation materials.
00850023120274 - physIQ Patient Kit2022-10-04 physIQ convenience kit including biosensors, mobile hub and skin preparation materials.
00850023120250 - physIQ Patient Kit2022-07-06 physIQ convenience kit including biosensors and skin preparation materials.
00850023120243 - physIQ Patient Kit2022-06-21 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio
00850023120236 - physIQ Patient Kit2022-05-30 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio
00850023120212 - physIQ Patient Kit2022-04-11 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio
00850023120229 - physIQ Patient Kit2022-04-11 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio
00850023120205 - physIQ Patient Kit2022-03-14 physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparatio

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