FDA.reportPublic FDA data

Fever therometer

Primary DI
00817746020274
Brand
Fever therometer
Company
BETTER BASICS, INC.
Model
MP-IRT350-US
Published
2016-11-18
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
K131243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131243000NON-CONTACT INFRARED THERMOMETERShenzhen Jumper Medical Equipment Co., Ltd.2013-11-12FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817746020281PackageGS11In Commercial Distribution
00817746020298PackageGS150In Commercial Distribution
00817746020274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817746020281008177460202818177460202810817746020281
00817746020298008177460202988177460202980817746020298
00817746020274008177460202748177460202740817746020274

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013029698
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817746020366Pulse MassagerMP-TENS-1102016-11-18
00817746020397Pulse MassagerMP-TENS310-US2016-11-18
00817746020915Pulse MassagerMP-TENS510-US2017-05-26
00817746021226Pulse OximeterMP-OX3002017-09-15
00817746020151Pulse oximeterMP-OX150-US2016-11-18
00817746020182Pulse oximeterMP-OX200-US2016-11-18
00817746020212Pulse oximeterMP-OX250-US2016-11-18
00817746026665Fever ThermometerMP-IRT4502017-09-15
00817746020243Fever therometerMP-TM21-US2016-11-18
00817746020007blood pressure monitorMP-BPM20A-US2016-11-18
00817746020038blood pressure monitorMP-BPM50W-US2016-11-18
00817746020069blood pressure monitorMP-BPMW60-US2016-11-18
00817746020090blood pressure monitorMP-BPMA70-US2016-11-18
00817746020120blood pressure monitor MP-BPM80A-US2016-11-18
00817746020304Body fat scaleSW-SBS5002016-11-18
00817746021233Pulse OximeterMP-OX3002017-09-15
00817746021325Fever ThermometerMP-IRT4502017-09-15
00817746020335Body fat scaleSW-SBS7002017-01-17
00817746020342Body fat scaleSW-SBS7002017-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22