TRACE 1 5520

GUDID 30853512006487

ECG Electrodes

NIKOMED USA

Electrocardiographic electrode, single-use
Primary Device ID30853512006487
NIH Device Record Key32f7f4bb-4507-42fe-869b-aaed4514d81e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRACE 1
Version Model Number5520
Catalog Number5520
Company DUNS073648341
Company NameNIKOMED USA
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

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100853512006486 [Unit of Use]
GS110853512006483 [Primary]
GS120853512006480 [Package]
Contains: 10853512006483
Package: Bx [10 Units]
In Commercial Distribution
GS130853512006487 [Package]
Contains: 20853512006480
Package: Cs [12 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 Date2019-04-04
Device Publish Date2017-04-17

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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