NeoLead Mini N300B

GUDID 00812594011740

NEOTECH PRODUCTS, INC.

Electrocardiographic electrode, single-use
Primary Device ID00812594011740
NIH Device Record Key05cbd81f-9d55-448c-9345-791b102349ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoLead Mini
Version Model Number812594011740
Catalog NumberN300B
Company DUNS198013435
Company NameNEOTECH PRODUCTS, INC.
Device Count1
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812594011740 [Primary]

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-14

On-Brand Devices [NeoLead Mini]

00812594011740812594011740
10812594011747Electrode (Box of 20)

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