NIKOTRACE 6559

GUDID 20853512006886

ECG Electrodes

NIKOMED USA

Electrocardiographic electrode, single-use
Primary Device ID20853512006886
NIH Device Record Keye6b3d5bc-250e-42ad-bf45-8e228637afde
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIKOTRACE
Version Model Number6559
Catalog Number6559
Company DUNS073648341
Company NameNIKOMED USA
Device Count60
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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

Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com
Phone+1(800)355-6456
Emailinfo@nikomedusa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100853512006882 [Unit of Use]
GS110853512006889 [Primary]
GS120853512006886 [Package]
Contains: 10853512006889
Package: Bx [10 Units]
In Commercial Distribution
GS130853512006883 [Package]
Package: Cs [12 Units]
In Commercial Distribution

FDA Product Code

DRXElectrode, electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-31
Device Publish Date2025-03-21

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20853512006862ECG Electrodes
20853512006855ECG Electrodes
20853512006848ECG Electrodes
20853512006831ECG Electrodes
00853512006820ECG Electrodes
20853512006817ECG Electrodes

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