Corpuls 19101.19
GUDID 35060842920238
ECG Electrode
NISSHA MEDICAL TECHNOLOGIES LTD
Electrocardiographic electrode, single-use| Primary Device ID | 35060842920238 |
| NIH Device Record Key | 8ca6a48f-ddd1-4d69-ba9e-75053c66a707 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Corpuls |
| Version Model Number | 1019CO |
| Catalog Number | 19101.19 |
| Company DUNS | 671405566 |
| Company Name | NISSHA MEDICAL TECHNOLOGIES LTD |
| Device Count | 50 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060842920237 [Unit of Use] |
| GS1 | 15060842920234 [Primary] |
| GS1 | 35060842920238 [Package] Contains: 15060842920234 Package: Inner Box [400 Units] In Commercial Distribution |
| GS1 | 55060842920232 [Package] Package: Shipping Carton [4800 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 | 2025-02-26 |
| Device Publish Date | 2025-02-18 |
Devices Manufactured by NISSHA MEDICAL TECHNOLOGIES LTD
| 35060842920238 - Corpuls | 2025-02-26ECG Electrode |
| 35060842920238 - Corpuls | 2025-02-26 ECG Electrode |
| 35060842920146 - Dräger | 2024-03-11 ECG Electrode |
| 35060842920153 - Dräger | 2024-03-11 ECG Electrode |
| 35060842920023 - Stryker | 2022-08-25 Neutral Electrodes intended to be used in combination with the device “Stryker MultiGen 2 RF Generator” |
| 15060441917628 - Boston Scientific | 2022-06-29 Neutral Electrode |
| 15060441917642 - Boston Scientific | 2022-06-29 Neutral Electrode |
| 35060441919992 - Maestro | 2022-02-04 Neutral Electrode |
| 35060441919244 - Swaroplate | 2021-05-07 Neutral Electrode |
Trademark Results [Corpuls]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CORPULS 79230886 not registered Live/Pending |
GS Elektromedizinische Geräte G. Stemple GmbH 2017-06-26 |
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