FDA.reportPublic FDA data

Fever Thermometer

Primary DI
00817746021325
Brand
Fever Thermometer
Company
BETTER BASICS, INC.
Model
MP-IRT450
Published
2017-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00817746021325PackageGS1100In Commercial Distribution
00817746025552PackageGS11In Commercial Distribution
00817746026665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817746021325008177460213258177460213250817746021325
00817746025552008177460255528177460255520817746025552
00817746026665008177460266658177460266650817746026665

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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#

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
00817746020274Fever therometerMP-IRT350-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
00817746020335Body fat scaleSW-SBS7002017-01-17
00817746020342Body fat scaleSW-SBS7002017-01-17

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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
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