THERMOGARD 51-7310
GUDID 20653405007446
THERMOGARD DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR
Conmed Corporation
Circulating immune complex (CIC) IVD, reagent| Primary Device ID | 20653405007446 |
| NIH Device Record Key | aca86f5c-3c89-461d-a795-f239b2b17dd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THERMOGARD |
| Version Model Number | 51-7310 |
| Catalog Number | 51-7310 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 80 |
| 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 | false |
| 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(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 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405007442 [Unit of Use] |
| GS1 | 10653405007449 [Primary] |
| GS1 | 20653405007446 [Package] Contains: 10653405007449 Package: BOX [80 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140658
FDA Product Code
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
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 | 2022-11-28 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [THERMOGARD]
| 30653405986588 | THERMOGARD DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR |
| 20653405049958 | THERMOGARD PEDIATRIC DISPERSIVE ELECTRODE |
| 20653405031267 | THERMOGARD DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR |
| 20653405007491 | THERMOGARD DISPERSIVE ELECTRODE |
| 20653405007477 | THERMOGARD PEDIATRIC DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR |
| 30845854650138 | THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE |
| 20653405013782 | THERMOGARD PLUS ABC DISPERSIVE ELECTRODE |
| 20653405013768 | THERMOGARD PLUS ABC PEDIATRIC DUAL DISPERSIVE ELECTRODE |
| 20653405007446 | THERMOGARD DUAL DISPERSIVE ELECTRODE, CONTACT QUALITY MONITOR |
Trademark Results [THERMOGARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THERMOGARD 97915957 not registered Live/Pending |
Thermogard Global Limited 2023-05-01 |
 THERMOGARD 79332351 not registered Live/Pending |
THERMOGARD GLOBAL LIMITED 2021-01-18 |
 THERMOGARD 78963352 not registered Dead/Abandoned |
THERMOGARD HURRICANE PROTECTION, INC. 2006-08-29 |
 THERMOGARD 77102275 not registered Dead/Abandoned |
Entegris, Inc. 2007-02-08 |
 THERMOGARD 76612187 3069841 Dead/Cancelled |
Polyonics, Inc. 2004-09-15 |
 THERMOGARD 75274358 2222003 Dead/Cancelled |
WAYNE-DALTON CORP. 1997-04-14 |
 THERMOGARD 75084289 2086562 Live/Registered |
CONMED CORPORATION 1996-04-05 |
 THERMOGARD 72032936 0664921 Dead/Expired |
EXOMET, INCORPORATED 1957-07-01 |
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