FDA.reportPublic FDA data

AGE

Primary DI
06958682800293
Brand
AGE
Company
AGELESS HEALTH INDUSTRIAL LIMITED
Model
BT-302
Device description
The electronic thermometer consists of temperature sensors, liquid crystal display, button batteries, special integrated circuits and other electronic components. Compared with the traditional mercury glass thermometer, the method has the advantages of convenient reading, short measuring time, high measuring accuracy, memory and buzzing prompt
Published
2017-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152508000Ageless Health Medical Digital ThermometerDongguan Ageless Health Industrial Co., Ltd.2015-12-31FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06958682800293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06958682800293069586828002936958682800293

GMDN Terms#

Term, Definition table
TermDefinition
Continuous electronic patient thermometer, battery-poweredA battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421298453
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06958682800057AGEBW-6012017-10-29
06958682800071AGEBW-606S2017-10-29
06958682800088AGEBA-8012017-10-29
06958682800101AGEBA-8062017-10-29
06958682800125AGEBW-6022017-10-29
06958682800149AGEBW-6032017-10-29
06958682800163AGEBA-8022017-10-29
06958682800187AGEBA-8032017-10-29
06958682800224AGEBA-8112017-10-29
06958682800255AGEBA-8122017-10-29
06958682800279AGEBA-8132017-10-29
06958682800286AGEBT-3012017-10-29
06958682800309AGEBT-3032017-10-29
06958682800316AGEBT-3052017-10-29
06958682800323AGEBT-3062017-10-29
06958682800330AGEBT-3082017-10-29
06958682800347AGEBT-3112017-10-29
06958682800354AGEBT-3182017-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22