EKG Patch™ (Cable) MGCBLSP

GUDID 00850018485029

Cable, Electrode

NULINE SENSORS, LLC

Electrocardiographic lead set, reusable
Primary Device ID00850018485029
NIH Device Record Keycd6213b1-5f60-4c4d-8b6b-bf27b7a3f896
Commercial Distribution StatusIn Commercial Distribution
Brand NameEKG Patch™ (Cable)
Version Model NumberCable
Catalog NumberMGCBLSP
Company DUNS079231054
Company NameNULINE SENSORS, LLC
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com
Phone407-473-0765
Emaileve.gould@nulinesensors.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018485029 [Primary]

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-09
Device Publish Date2020-07-01

Devices Manufactured by NULINE SENSORS, LLC

10850018485002 - EKG Patch™ (Medium)2020-07-09 Electrode, Electrocardiograph
10850018485019 - EKG Patch™ (Large)2020-07-09 Electrode, Electrocardiograph
00850018485029 - EKG Patch™ (Cable)2020-07-09Cable, Electrode
00850018485029 - EKG Patch™ (Cable)2020-07-09 Cable, Electrode

Trademark Results [EKG Patch]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EKG PATCH
EKG PATCH
85806457 not registered Dead/Abandoned
V-Patch Medical Systems 1 PTY LTD
2012-12-19

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.