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]

FDA Product Code

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

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