BabyTemp by Baby Doppler

GUDID 00628055787839

BabyTemp DuoSmart Digital Infrared Thermometer by Baby Doppler with Mobile Application to track and record temperature readings

DAGAMMA INC.

Infrared patient thermometer, skin
Primary Device ID00628055787839
NIH Device Record Key2184086f-949a-47eb-8a3d-f0861dfef866
Commercial Distribution StatusIn Commercial Distribution
Brand NameBabyTemp by Baby Doppler
Version Model NumberDuoSmart Thermometer
Company DUNS080572190
Company NameDAGAMMA INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100628055787839 [Primary]
GS110628055787836 [Package]
Package: Product Packaging [1 Units]
In Commercial Distribution
GS120628055787833 [Package]
Contains: 10628055787836
Package: Master Carton [60 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-12-04
Device Publish Date2020-05-28

Devices Manufactured by DAGAMMA INC.

00628055787440 - Dagamma2021-11-10 The Dagamma DP200 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen le
10628055787454 - Dagamma2021-11-10 The Dagamma DP250 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen le
00628055787839 - BabyTemp by Baby Doppler2020-12-04BabyTemp DuoSmart Digital Infrared Thermometer by Baby Doppler with Mobile Application to track and record temperature readings
00628055787839 - BabyTemp by Baby Doppler2020-12-04 BabyTemp DuoSmart Digital Infrared Thermometer by Baby Doppler with Mobile Application to track and record temperature readings
00628055787242 - Baby Doppler2019-06-07 Baby Temp Instant Non-Contact Infrared Thermometer
00628055787013 - Baby Doppler2018-07-06 The Sonoline B Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve an
00628055787051 - Baby Doppler2018-07-06 The Sonoline B Fetal Doppler is a 3MHz ultrasonic Doppler that allows expectant mothers and health care professionals to retriev
00628055787259 - Dagamma2018-07-06 DT1000 Digital Infrared Forehead and Ear Thermometer by Dagamma
00628055787266 - Baby Doppler2018-07-06 The Ultraline 1000 is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen t

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