SOFTRACE 2350-005
GUDID 20653405052934
SOFTRACE REPOSITIONABLE,LG,5
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 Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use| Primary Device ID | 20653405052934 |
| NIH Device Record Key | 4d623af5-f12c-493c-a64a-9fc9738d288c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOFTRACE |
| Version Model Number | 2350-005 |
| Catalog Number | 2350-005 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 300 |
| 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 | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage 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 | 00653405052930 [Unit of Use] |
| GS1 | 10653405052937 [Primary] |
| GS1 | 20653405052934 [Package] Contains: 10653405052937 Package: CASE [300 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 | 2024-02-13 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [SOFTRACE]
| 20653405064135 | SOFTRACE MEDIUM RTL |
| 20653405064128 | SOFTRACE SMALL RTL |
| 20653405038990 | SOFTRACE, NEONATAL/PEDIATRIC ECG ELECTRODE |
| 20653405038983 | SOFTRACE, NEONATAL/PEDIATRIC ECG ELECTRODE |
| 20653405038976 | SOFTRACE LIMB BAND, NEONATAL/PEDIATRIC ECG ELECTRODE |
| 20653405052941 | SOFTRACE REPOSITION,RTL,LG,3 |
| 20653405052927 | SOFTRACE REPOSITIONABLE,LG,3 |
| 20653405055973 | SOFTRACE REPOSITION,RTL,SM,3 |
| 20653405055966 | SOFTRACE,REPOSITION,RTL,MD,3 |
| 20653405052958 | SOFTRACE REPOSITION,RTL,LG,5 |
| 20653405052934 | SOFTRACE REPOSITIONABLE,LG,5 |
| 20653405039003 | SOFTRACE REPOSITIONABLE,SM,3 |
| 20653405033193 | SOFTRACE REPOSITIONABLE,MD,3 |
Trademark Results [SOFTRACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOFTRACE 73800253 1600627 Live/Registered |
ANDOVER MEDICAL INCORPORATED 1989-05-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.