Resting Tab Type Electrodes

GUDID 30812345024723

Electrodes

MORTARA INSTRUMENT, INC.

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use
Primary Device ID30812345024723
NIH Device Record Key9828c2ac-94b0-45e5-afd0-99f44feb8737
Commercial Distribution StatusIn Commercial Distribution
Brand NameResting Tab Type Electrodes
Version Model Number9300-033-50
Company DUNS062046149
Company NameMORTARA INSTRUMENT, INC.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100812345024722 [Unit of Use]
GS110812345024729 [Primary]
GS120812345024726 [Package]
Contains: 10812345024729
Package: [5 Units]
In Commercial Distribution
GS130812345024723 [Package]
Contains: 20812345024726
Package: [10 Units]
In Commercial Distribution

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-06-29
Device Publish Date2016-09-24

Devices Manufactured by MORTARA INSTRUMENT, INC.

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20812345024238 - Quick-Trace Multi-purpose ECG electrodes2020-06-29 Electrodes
30812345024686 - CardioSens/Ultra II2020-06-29 Electrodes
30812345024723 - Resting Tab Type Electrodes2020-06-29Electrodes
30812345024723 - Resting Tab Type Electrodes2020-06-29 Electrodes
20812345024733 - ECG Monitoring Electrodes2020-06-29 Electrodes
21081234502474 - Quik-Prep2020-06-29 Electrodes

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