Home GUDID 20884521817545 Mon-a-Therm
Primary DI 20884521817545
Brand Mon-a-Therm
Company Covidien LP
Model 90045
Device description Skin Temperature Probe 400TM
Published 2022-10-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FLL Thermometer, electronic, clinical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FLL Continuous Measurement Thermometer General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20884521817545 Package GS1 50 In Commercial Distribution 30884521817542 Package GS1 2 In Commercial Distribution 10884521817548 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20884521817545 20884521817545 30884521817542 30884521817542 10884521817548 10884521817548
GMDN Terms# Term, Definition table Term Definition General-purpose patient temperature probe, single-use A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 12 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature -25 Degrees Celsius 55 Degrees Celsius Handling Environment Temperature 15 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 12 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -25 Degrees Celsius 55 Degrees Celsius Storage Environment Temperature 15 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 058614483 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860016681507 UNIVERHEALTH Hangzhou Universal Electronic Co.,Ltd. FLL 2026-10-28 09120095900809 SteadyTemp SteadySense GmbH FLL 2026-10-21 06973660370520 Mintti Suzhou Melodicare Medical Technology Co., Ltd. FLL 2026-10-10 00195278949752 TruSignal SpO2 MM 3.0M GE Healthcare Finland Oy FLL 2026-10-04 00195278949769 TruSignal SpO2 MM 1.8M GE Healthcare Finland Oy FLL 2026-10-04 00198953002186 Carescape Dock F0 GE Healthcare Finland Oy FLL 2026-10-04 00198953009567 Carescape ONE GE Healthcare Finland Oy FLL 2026-10-04 00749756389181 DeRoyal DEROYAL INDUSTRIES, INC. FLL 2026-09-21 00749756389204 DeRoyal DEROYAL INDUSTRIES, INC. FLL 2026-09-21 06944413835153 Telemetry Monitor Edan Instruments, Inc. FLL 2026-08-26 06944413835214 Telemetry Monitor Edan Instruments, Inc. FLL 2026-08-26 00885403523437 HemoSphere Alta Becton, Dickinson And Company FLL 2026-08-06 00885403523451 HemoSphere Alta Becton, Dickinson And Company FLL 2026-08-06 00885403523475 HemoSphere Alta Becton, Dickinson And Company FLL 2026-08-06 06970289030859 foreverlittle Hetaida Technology Co., Ltd FLL 2026-07-28 06953825911638 ZKZO Shenzhen Urion Technology Co., Ltd FLL 2026-07-23 B353UB25511 UbiqVue Multiparameter Lifesignals, Inc. FLL 2026-07-20 06972040114334 N/A Shenzhen AOJ Medical Technology Co., Ltd FLL 2026-07-11 06972040114341 N/A Shenzhen AOJ Medical Technology Co., Ltd FLL 2026-07-11 06972040115522 N/A Shenzhen AOJ Medical Technology Co., Ltd FLL 2026-07-11 06931973457093 Caremed Shenzhen Caremed Medical Technology Co., Ltd. FLL 2026-07-09 06931973457109 Caremed Shenzhen Caremed Medical Technology Co., Ltd. FLL 2026-07-09 06970758502641 Caremed Shenzhen Caremed Medical Technology Co., Ltd. FLL 2026-07-09 06970758508865 Caremed Shenzhen Caremed Medical Technology Co., Ltd. FLL 2026-07-09 00850086928008 SENSINEL™ CPM BASE STATION Analog Devices, Inc. FLL 2026-06-03 00850086928015 SENSINEL™ CPM WEARABLE Analog Devices, Inc. FLL 2026-06-03 00850086928022 SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) Analog Devices, Inc. FLL 2026-06-03 00850086928039 SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) Analog Devices, Inc. FLL 2026-06-03 08720256776567 Corsano CardioWatch 287-2 System Corsano Health B.V. FLL 2026-06-02 06926347900459 joybabe Shenzhen Brav Electronic Technologies Co., Ltd. FLL 2026-06-01
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