Home GUDID 04710953421321 TekCare Infrared Thermometer
Primary DI 04710953421321
Brand TekCare Infrared Thermometer
Company AVITA CORPORATION
Model TS46
Device description The device is an infrared thermometer intended for the intermittent measurement of human body temperature in people of all ages.
Published 2018-12-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false 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 04710953421321 Package GS1 40 In Commercial Distribution 04710953421314 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04710953421321 04710953421321 4710953421321 04710953421314 04710953421314 4710953421314
GMDN Terms# Term, Definition table Term Definition Infrared patient thermometer, ear A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 658023275 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true 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 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 06942284618073 One Step® JOYTECH HEALTHCARE CO.,LTD FLL 2026-05-29 00884392020613 Safety 1st DOREL JUVENILE GROUP, INC. FLL 2026-05-28 B3944060056010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3944670047010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945000030010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945300046010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945300054010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945300054020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945600013020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048030 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048040 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048050 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048060 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048070 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048080 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048090 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700048100 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700051020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700063010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700064010 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 B3945700068020 WVSM Pro, Wireless Vital Signs Monitor Professional ATHENA GTX, INC. FLL 2026-05-27 08698870325211 FMT METKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETI FLL 2026-04-22