Mon-a-Therm
GUDID 20884521826424
Foley with Temperature Sensor 400TM
Covidien LP
Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial| Primary Device ID | 20884521826424 |
| NIH Device Record Key | 418f6b1b-3471-4756-a973-11ac09da4203 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mon-a-Therm |
| Version Model Number | 90053 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| 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(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
| Catheter Gauge | 8 French |
Operating and Storage Conditions
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between -13 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 12 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521826427 [Primary] |
| GS1 | 20884521826424 [Package] Contains: 10884521826427 Package: PACK_OR_INNER_PACK [10 Units] In Commercial Distribution |
| GS1 | 30884521826421 [Package] Package: CASE [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K831567
FDA Product Code
| KOD | CATHETER, UROLOGICAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-06 |
| Device Publish Date | 2023-05-29 |
On-Brand Devices [Mon-a-Therm]
| 10884521078062 | Foley with Temperature Sensor,400TM |
| 10884521078031 | Foley with Temperature Sensor,400TM |
| 20884521078021 | Foley with Temperature Sensor,400TM |
| 10884521078017 | Foley with Temperature Sensor,400TM |
| 20884521077598 | Foley with Temperature Sensor,400TM |
| 10884521077584 | Foley with Temperature Sensor,400TM |
| 20884521031576 | Skin Temperature Probe,400TM |
| 30884521031740 | Esophageal Stethoscope with Temperature Sensor,400TM |
| 10884521031739 | Esophageal Stethoscope with Temperature Sensor ;400TM |
| 30884521031726 | Esophageal Stethoscope with Temperature Sensor,400TM |
| 30884521031719 | Esophageal Stethoscope with Temperature Sensor,400TM |
| 30884521031603 | General Purpose Temperature Probe,400TM |
| 30884521031597 | General Purpose Temperature Probe,400TM |
| 10884521031586 | Tympanic Temperature Probe,400TM |
| 10884521706415 | Cable 400TM For Siemens Monitor Series SC |
| 10884521706408 | Cable 400TM For HP or Philips Monitors HP and Philips are trademarks of their respective owners. |
| 10884521706446 | Cable 400TM |
| 10884521706439 | Cable 400TM |
| 10884521706422 | Cable 400TM For 4070 Temperature Monitor |
| 10884521706392 | Cable 400TM For 4070 Temperature Monitor |
| 20884521817545 | Skin Temperature Probe 400TM |
| 20884521842882 | Cable 400TM;For Siemens Monitor Series SC |
| 20884521842875 | Cable 400TM;For HP (TM) or Philips (TM) Monitors HP and Philips are trademarks of their respecti |
| 20884521842868 | Cable 400TM;For use with 4070 Temperature Monitor |
| 20884521842851 | Cable 400TM;For Siemens Monitor Series SC |
| 20884521842844 | Cable 400TM;For HP (TM) or Philips (TM) Monitors HP and Philips are trademarks of their respecti |
| 20884521842837 | Cable 400TM;For 4070 Temperature Monitor |
| 30884521828395 | General Purpose Temperature Probe 400TM |
| 20884521828381 | General Purpose Temperature Probe 400TM |
| 20884521826455 | Foley with Temperature Sensor 400TM |
| 20884521826448 | Foley with Temperature Sensor 400TM |
| 30884521826438 | Foley with Temperature Sensor 400TM |
| 20884521826424 | Foley with Temperature Sensor 400TM |
| 30884521826414 | Foley with Temperature Sensor 400TM |
| 20884521826400 | Foley with Temperature Sensor 400TM |
| 20884521820927 | Esophageal Stethoscope with Temperature Sensor 400TM |
| 30884521820917 | Esophageal Stethoscope with Temperature Sensor 400TM |
| 20884521820903 | Esophageal Stethoscope with Temperature Sensor 400TM |
| 30884521820894 | Esophageal Stethoscope with Temperature Sensor 400TM |
Trademark Results [Mon-a-Therm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MON-A-THERM 97257795 not registered Live/Pending |
Covidien LP 2022-02-08 |
 MON-A-THERM 73130980 1083362 Live/Registered |
LABARGE, INC. 1977-06-20 |
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