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 Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

• Primary Device ID: 00628055787839
• NIH Device Record Key: 2184086f-949a-47eb-8a3d-f0861dfef866
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BabyTemp by Baby Doppler
• Version Model Number: DuoSmart Thermometer
• Company DUNS: 080572190
• Company Name: DAGAMMA INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055787839 [Primary]
GS1	10628055787836 [Package]; Package: Product Packaging [1 Units]; In Commercial Distribution
GS1	20628055787833 [Package]; Contains: 10628055787836; Package: Master Carton [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140681

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-04
• Device Publish Date: 2020-05-28

Devices Manufactured by DAGAMMA INC.

• 00628055787440 - Dagamma: 2021-11-10 The Dagamma DP200 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen le
• 10628055787454 - Dagamma: 2021-11-10 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 Doppler: 2020-12-04BabyTemp DuoSmart Digital Infrared Thermometer by Baby Doppler with Mobile Application to track and record temperature readings
• 00628055787839 - BabyTemp by Baby Doppler: 2020-12-04 BabyTemp DuoSmart Digital Infrared Thermometer by Baby Doppler with Mobile Application to track and record temperature readings
• 00628055787242 - Baby Doppler: 2019-06-07 Baby Temp Instant Non-Contact Infrared Thermometer
• 00628055787013 - Baby Doppler: 2018-07-06 The Sonoline B Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve an
• 00628055787051 - Baby Doppler: 2018-07-06 The Sonoline B Fetal Doppler is a 3MHz ultrasonic Doppler that allows expectant mothers and health care professionals to retriev
• 00628055787259 - Dagamma: 2018-07-06 DT1000 Digital Infrared Forehead and Ear Thermometer by Dagamma
• 00628055787266 - Baby Doppler: 2018-07-06 The Ultraline 1000 is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen t