NIKOPrep 2121/E 240

GUDID 00853512006776

Strips for Skin Preparation (Individual Pieces)

NIKOMED USA

Electrode skin abrasion pad
Primary Device ID00853512006776
NIH Device Record Keyc3a4fd37-722c-4375-a4d3-b7cb3b6fab04
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIKOPrep
Version Model Number2121/E 240
Catalog Number2121/E 240
Company DUNS073648341
Company NameNIKOMED USA
Device Count500
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100853512006776 [Unit of Use]
GS110853512006773 [Primary]

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 Date2022-10-27
Device Publish Date2022-10-19

On-Brand Devices [NIKOPrep]

00853512006776Strips for Skin Preparation (Individual Pieces)
00853512006769Strips for Skin Preparation (1 card of 5 pieces)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.