EKG Patch™ (Large) MGLRG
GUDID 10850018485019
Electrode, Electrocardiograph
NULINE SENSORS, LLC
Ambulatory recorder conductive patch| Primary Device ID | 10850018485019 |
| NIH Device Record Key | 06fce679-7028-4ed7-85fe-8accb9422ba8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EKG Patch™ (Large) |
| Version Model Number | Large |
| Catalog Number | MGLRG |
| Company DUNS | 079231054 |
| Company Name | NULINE SENSORS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com | |
| Phone | 407-473-0765 |
| eve.gould@nulinesensors.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850018485012 [Primary] |
| GS1 | 10850018485019 [Package] Contains: 00850018485012 Package: box [10 Units] In Commercial Distribution |
FDA Product Code
| DRX | Electrode, Electrocardiograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-09 |
| Device Publish Date | 2020-07-01 |
Devices Manufactured by NULINE SENSORS, LLC
| 10850018485002 - EKG Patch™ (Medium) | 2020-07-09 Electrode, Electrocardiograph |
| 10850018485019 - EKG Patch™ (Large) | 2020-07-09Electrode, Electrocardiograph |
| 10850018485019 - EKG Patch™ (Large) | 2020-07-09 Electrode, Electrocardiograph |
| 00850018485029 - EKG Patch™ (Cable) | 2020-07-09 Cable, Electrode |
Trademark Results [EKG Patch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EKG PATCH 85806457 not registered Dead/Abandoned |
V-Patch Medical Systems 1 PTY LTD 2012-12-19 |
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