ULTRATRACE 1690-010
GUDID 20653405004193
ULTRATRACE 50 TP, WTGEL
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 Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use| Primary Device ID | 20653405004193 |
| NIH Device Record Key | 83617429-f2ce-43c7-a9e4-da49a63df07d |
| Commercial Distribution Discontinuation | 2022-09-29 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ULTRATRACE |
| Version Model Number | 1690-010 |
| Catalog Number | 1690-010 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 1000 |
| 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(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage 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 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405004199 [Unit of Use] |
| GS1 | 10653405004196 [Primary] |
| GS1 | 20653405004193 [Package] Contains: 10653405004196 Package: BOX [1000 Units] Discontinued: 2022-09-29 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K905446
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 | 2022-11-11 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [ULTRATRACE]
| 20653405004193 | ULTRATRACE 50 TP, WTGEL |
| 20653405004209 | ULTRATRACE 30 TP, WTGEL |
| 20653405004186 | ULTRATRACE ADULT ECG ELECTRODE |
Trademark Results [ULTRATRACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRATRACE 98176223 not registered Live/Pending |
DeepSight Technology, Inc. 2023-09-12 |
 ULTRATRACE 90015618 not registered Live/Pending |
Progenics Pharmaceuticals, Inc. 2020-06-23 |
 ULTRATRACE 79390539 not registered Live/Pending |
ULTRAHUMAN HEALTHCARE PRIVATE LIMITED 2023-10-04 |
 ULTRATRACE 78698536 3613887 Live/Registered |
Molecular Insight Pharmaceuticals, Inc. 2005-08-23 |
 ULTRATRACE 77024418 not registered Dead/Abandoned |
Molecular Insight Pharmaceuticals, Inc. 2006-10-18 |
 ULTRATRACE 74271158 1777122 Live/Registered |
CONMED CORPORATION 1992-04-30 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.