FDA.reportPublic FDA data

BabyTemp by Baby Doppler

Primary DI
00628055787839
Brand
BabyTemp by Baby Doppler
Company
DAGAMMA INC.
Model
DuoSmart Thermometer
Device description
BabyTemp DuoSmart Digital Infrared Thermometer by Baby Doppler with Mobile Application to track and record temperature readings
Published
2020-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K140681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140681000BELTER INFRA-RED EAR THERMOMETERShenzhen Belter Health Measurement and Analysis TE2014-08-21FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628055787836PackageGS11In Commercial Distribution
20628055787833PackageGS160In Commercial Distribution
00628055787839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062805578783610628055787836
2062805578783320628055787833
00628055787839006280557878396280557878390628055787839

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered 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
080572190
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055787389DagammaFinger Pulse Oximeter DP-100 Blue2017-03-30
00628055787396DagammaFinger Pulse Oximeter DP-100 Black2017-03-30
00628055787402DagammaFinger Pulse Oximeter DP-100 White2017-03-30
00628055787426DagammaFinger Pulse Oximeter DP-100 Yellow2017-03-30
00628055787433DagammaFinger Pulse Oximeter DP-100 Pink2017-03-30
00628055787570DagammaFinger Pulse Oximeter DP-150 Blue2017-10-06
00628055787587DagammaFinger Pulse Oximeter DP-150 Black2017-10-06
00628055787594DagammaFinger Pulse Oximeter DP-150 White2017-10-06
00628055787617DagammaFinger Pulse Oximeter DP-150 Yellow2017-10-06
00628055787624DagammaFinger Pulse Oximeter DP-150 Pink2017-10-06
00628055787457DagammaFinger Pulse Oximeter DP2502020-05-28
00628055787440DagammaFinger Pulse Oximeter DP2002020-05-28
10628055787454DagammaFinger Pulse Oximeter DP2502020-05-28
00628055787242Baby DopplerBabyTemp 1 Sec ThermometerAL65005002019-05-23
00628055787259DagammaDT10002017-03-30
00628055787013Baby DopplerSonoline B Blue 3MHz2017-03-30
00628055787051Baby DopplerSonoline B Pink 3MHz2017-03-30
00628055787266Baby DopplerUltraline 1000 Blue 2.5MHz2017-09-28

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Primary DI, Brand, Company table
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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
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