SoWeCare

GUDID 06973399670014

shen zhen shi te ken dian zi you xian gong si

Infrared patient thermometer, skin

• Primary Device ID: 06973399670014
• NIH Device Record Key: 0e55f6cd-0d66-4d76-9fc9-65140230f117
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoWeCare
• Version Model Number: LX-26E
• Company DUNS: 553091027
• Company Name: shen zhen shi te ken dian zi you xian gong si
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973399670014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160816

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: 2020-06-16