WITHINGS

GUDID 04719873310012

SCT01 is the device for the measurement of body temperature.

YA HORNG ELECTRONIC CO., LTD.

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 04719873310012
• NIH Device Record Key: 697d49a1-beb3-4ed8-815b-40330a89c71c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WITHINGS
• Version Model Number: SCT01
• Company DUNS: 656103819
• Company Name: YA HORNG ELECTRONIC 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: false
• Serial Number: true
• 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	04719873310012 [Primary]
GS1	14719873310019 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160544

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: 2018-03-29
• Device Publish Date: 2016-10-07

On-Brand Devices [WITHINGS]

• 14719873310033: BP-801 is the device for the measurement of blood pressure & pulse rate of patient.
• 04719873310029: BP-801 is the device for the measurement of blood pressure & pulse rate of patient.
• 04719873310012: SCT01 is the device for the measurement of body temperature.
• 04719873310005: BP-801 is the device for the measurement of blood pressure & pulse rate of patient