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 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