VitalConnect 14-day Cardiac Monitoring Kit 1400-02

GUDID 00850490007443

VitalConnect 14-day Cardiac Monitoring Kit

Vital Connect, Inc.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system
Primary Device ID00850490007443
NIH Device Record Key0ff4b4df-d53b-45c4-840f-467115b928e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitalConnect 14-day Cardiac Monitoring Kit
Version Model Number1400-02
Catalog Number1400-02
Company DUNS944642730
Company NameVital Connect, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850490007443 [Primary]
GS100850490007443 [Primary]
GS100850490007443 [Primary]
GS100850490007443 [Primary]

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 - VistaPhone2020-11-10 Vista Phone relay device
00850490007443 - VitalConnect 14-day Cardiac Monitoring Kit2020-11-10VitalConnect 14-day Cardiac Monitoring Kit
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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