DYNA/TRACE 1500-001
GUDID 10653405003601
DYNA/TRACE ADULT ECG ELECTRODE
Conmed Corporation
Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use| Primary Device ID | 10653405003601 |
| NIH Device Record Key | de69dd34-43df-43ce-80a0-a9935dcb64de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DYNA/TRACE |
| Version Model Number | 1500-001 |
| Catalog Number | 1500-001 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 600 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405003604 [Unit of Use] |
| GS1 | 10653405003601 [Primary] |
| GS1 | 20653405003608 [Package] Package: CARTON [600 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K991105
FDA Product Code
| DRX | Electrode, electrocardiograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-11-04 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [DYNA/TRACE]
| 10653405003649 | DYNATRACE 30 FM, WTGEL |
| 10653405003632 | DYNA/TRACE ADULT ECG ELECTRODE |
| 10653405003625 | DYNA/TRACE ADULT ECG ELECTRODE |
| 10653405003618 | DYNA/TRACE ADULT ECG ELECTRODE |
| 10653405003601 | DYNA/TRACE ADULT ECG ELECTRODE |
| 20653405003721 | DYNA/TRACE STRESS, ADULT DIAGNOSTIC ECG ELECTRODE |
Trademark Results [DYNA/TRACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYNA/TRACE 73464364 1319190 Live/Registered |
Andover Medical Incorporated 1984-02-06 |
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