VistaPhone 8303-01

GUDID 00850490007436

Vista Phone relay device

Vital Connect, Inc.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system
Primary Device ID00850490007436
NIH Device Record Key9c43cfd1-0453-44f7-96cf-c4e34a283222
Commercial Distribution StatusIn Commercial Distribution
Brand NameVistaPhone
Version Model Number8303-01
Catalog Number8303-01
Company DUNS944642730
Company NameVital Connect, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850490007436 [Primary]
GS100850490007436 [Primary]
GS100850490007436 [Primary]
GS100850490007436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

Devices Manufactured by Vital Connect, Inc.

00850490007375 - VistaCenter2020-11-10 Multipatient user interface, convenience view of VistaPoint
00850490007382 - VistaPoint Software User Interface2020-11-10 User interface in the patient's room
00850490007399 - VistaTablet2020-11-10 Vista Tablet relay device
00850490007412 - Vista Solution 3 10-day Evaluation Kit2020-11-10 Vista Solution 3 10-day Evaluation Kit
00850490007429 - VistaTablet2020-11-10 VistaTablet Relay Device
00850490007436 - VistaPhone2020-11-10Vista Phone relay device
00850490007436 - VistaPhone2020-11-10 Vista Phone relay device
00850490007443 - VitalConnect 14-day Cardiac Monitoring Kit2020-11-10 VitalConnect 14-day Cardiac Monitoring Kit
00850490007450 - VitalPatch® RTM 2020-11-10 VitalPatch Biosensor

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