CARETALK

GUDID 16926408700209

The device is Non-Contact thermometer, which is intended to measure human body temperature

Shenzhen Dongdixin Technology Co.,Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 16926408700209
• NIH Device Record Key: 3a5a5941-f057-49f1-95e3-674e52145120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARETALK
• Version Model Number: TH5001N
• Company DUNS: 545301488
• Company Name: Shenzhen Dongdixin Technology Co.,Ltd.
• 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: false
• 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	06926408700202 [Primary]
GS1	16926408700209 [Package]; Contains: 06926408700202; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161735

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-27
• Device Publish Date: 2020-03-19

On-Brand Devices [CARETALK]

• 16926408700209: The device is Non-Contact thermometer, which is intended to measure human body temperature
• 06926408700455: The device is Non-Contact thermometer, which is intended to measure human body temperature