Mon-a-Therm 90053

GUDID 10884521078062

Foley with Temperature Sensor,400TM

Covidien LP

General-purpose patient temperature probe, single-use
Primary Device ID10884521078062
NIH Device Record Key24adc181-2a60-425a-ac02-6a03b18c12e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMon-a-Therm
Version Model Number90053
Catalog Number90053
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV;
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to UV

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521078062 [Package]
Contains: 30884521078066
Package: CASE [20 Units]
In Commercial Distribution
GS120884521078069 [Package]
Contains: 30884521078066
Package: PACK_OR_INNER_PACK [10 Units]
In Commercial Distribution
GS130884521078066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KODCATHETER, UROLOGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Mon-a-Therm]

10884521078062Foley with Temperature Sensor,400TM
10884521078031Foley with Temperature Sensor,400TM
20884521078021Foley with Temperature Sensor,400TM
10884521078017Foley with Temperature Sensor,400TM
20884521077598Foley with Temperature Sensor,400TM
10884521077584Foley with Temperature Sensor,400TM
20884521031576Skin Temperature Probe,400TM
30884521031740Esophageal Stethoscope with Temperature Sensor,400TM
10884521031739Esophageal Stethoscope with Temperature Sensor ;400TM
30884521031726Esophageal Stethoscope with Temperature Sensor,400TM
30884521031719Esophageal Stethoscope with Temperature Sensor,400TM
30884521031603General Purpose Temperature Probe,400TM
30884521031597General Purpose Temperature Probe,400TM
10884521031586Tympanic Temperature Probe,400TM
10884521706415Cable 400TM For Siemens Monitor Series SC
10884521706408Cable 400TM For HP or Philips Monitors HP and Philips are trademarks of their respective owners.
10884521706446Cable 400TM
10884521706439Cable 400TM
10884521706422Cable 400TM For 4070 Temperature Monitor
10884521706392Cable 400TM For 4070 Temperature Monitor
20884521817545Skin Temperature Probe 400TM
20884521842882Cable 400TM;For Siemens Monitor Series SC
20884521842875Cable 400TM;For HP (TM) or Philips (TM) Monitors HP and Philips are trademarks of their respecti
20884521842868Cable 400TM;For use with 4070 Temperature Monitor
20884521842851Cable 400TM;For Siemens Monitor Series SC
20884521842844Cable 400TM;For HP (TM) or Philips (TM) Monitors HP and Philips are trademarks of their respecti
20884521842837Cable 400TM;For 4070 Temperature Monitor
30884521828395General Purpose Temperature Probe 400TM
20884521828381General Purpose Temperature Probe 400TM
20884521826455Foley with Temperature Sensor 400TM
20884521826448Foley with Temperature Sensor 400TM
30884521826438Foley with Temperature Sensor 400TM
20884521826424Foley with Temperature Sensor 400TM
30884521826414Foley with Temperature Sensor 400TM
20884521826400Foley with Temperature Sensor 400TM
20884521820927Esophageal Stethoscope with Temperature Sensor 400TM
30884521820917Esophageal Stethoscope with Temperature Sensor 400TM
20884521820903Esophageal Stethoscope with Temperature Sensor 400TM
30884521820894Esophageal Stethoscope with Temperature Sensor 400TM

Trademark Results [Mon-a-Therm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MON-A-THERM
MON-A-THERM
97257795 not registered Live/Pending
Covidien LP
2022-02-08
MON-A-THERM
MON-A-THERM
73130980 1083362 Live/Registered
LABARGE, INC.
1977-06-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.