Quick-Trace Multi-purpose ECG electrodes

GUDID 20812345024238

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 ID20812345024238
NIH Device Record Key1653c837-20ef-4344-bab5-683f6721d2f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuick-Trace Multi-purpose ECG electrodes
Version Model Number000310-001
Company DUNS062046149
Company NameMORTARA INSTRUMENT, INC.
Device Count30
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 Latexfalse
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 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100812345024234 [Unit of Use]
GS110812345024231 [Primary]
GS120812345024238 [Package]
Contains: 10812345024231
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-29
Device Publish Date2016-09-24

Devices Manufactured by MORTARA INSTRUMENT, INC.

21081234502471 - Quik-Prep2020-07-20 Electrodes
10812345022176 - Clear Choice Adapter2020-06-29 ECG Adapter
10812345023050 - Snap Adapter2020-06-29 ECG Adapter
20812345024238 - Quick-Trace Multi-purpose ECG electrodes2020-06-29Electrodes
20812345024238 - Quick-Trace Multi-purpose ECG electrodes2020-06-29 Electrodes
30812345024686 - CardioSens/Ultra II2020-06-29 Electrodes
30812345024723 - Resting Tab Type Electrodes2020-06-29 Electrodes
20812345024733 - ECG Monitoring Electrodes2020-06-29 Electrodes
21081234502474 - Quik-Prep2020-06-29 Electrodes
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.