TRACE 1 5520-10

GUDID 00853512006806

ECG Electrodes

NIKOMED USA

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 ID00853512006806
NIH Device Record Keyb4636379-9635-425f-b841-1d0fe4bbb8da
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACE 1
Version Model Number5520-10
Catalog Number5520-10
Company DUNS073648341
Company NameNIKOMED USA
Device Count10
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

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
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
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100853512006806 [Unit of Use]
GS110853512006803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-04-03
Device Publish Date2023-03-24

On-Brand Devices [TRACE 1]

30853512006487ECG Electrodes
00853512006653ECG Electrodes
00853512006806ECG Electrodes

Trademark Results [TRACE 1]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRACE 1
TRACE 1
76425825 2826026 Live/Registered
Nikomed, U.S.A., Inc.
2002-06-26
TRACE 1
TRACE 1
75677650 not registered Dead/Abandoned
Nikomed, U.S.A., Inc.
1999-04-07

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