OMNITRACE 3600-003
GUDID 20653405001093
OMNITRACE FOAM, ADULT ECG ELECTRODE
Conmed Corporation
Electrocardiographic electrode, single-use| Primary Device ID | 20653405001093 |
| NIH Device Record Key | de0759f5-050d-4992-af6e-e51bf91a1199 |
| Commercial Distribution Discontinuation | 2023-03-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | OMNITRACE |
| Version Model Number | 3600-003 |
| Catalog Number | 3600-003 |
| 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 | true |
| Expiration Date | false |
| 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 | |
| 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
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405001099 [Unit of Use] |
| GS1 | 10653405001096 [Primary] |
| GS1 | 20653405001093 [Package] Contains: 10653405001096 Package: CASE [600 Units] Discontinued: 2023-03-27 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091856
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 | 2023-03-27 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [OMNITRACE]
| 10653405001102 | Adult ECG Foam, Conductive Adhesive Gel Carbon Snap 50/pk 1000/case |
| 10653405000662 | Adult ECG Foam, Conductive Adhesive Gel Metal Snap 50/pk 1000/case |
| 20653405001086 | OMNITRACE RTL ADULT ECG ELECTRODE |
| 20653405001079 | OMNITRACE FOAM, ADULT ECG ELECTRODE |
| 20653405001062 | OMNITRACE RTL ADULT ECG ELECTRODE |
| 20653405001093 | OMNITRACE FOAM, ADULT ECG ELECTRODE |
Trademark Results [OMNITRACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNITRACE 88206840 5793255 Live/Registered |
Omnitrace Corp. 2018-11-27 |
 OMNITRACE 75167292 2136309 Live/Registered |
MERCK KGAA 1996-09-17 |
 OMNITRACE 75167291 2136308 Live/Registered |
MERCK KGAA 1996-09-17 |
 OMNITRACE 74002771 not registered Dead/Abandoned |
CAERE CORPORATION 1989-11-16 |
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