HCS

GUDID 06971463320032

The Infrared non-contact Thermometer is intended to measurement forehead temperature at home or hospital, for patients of all ages by Infrared sensing probe.

Dongguan HCS Electronics Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 06971463320032
• NIH Device Record Key: e794c3ed-14c5-4e17-a558-62db9584cb16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HCS
• Version Model Number: HET-R121
• Company DUNS: 544532803
• Company Name: Dongguan HCS Electronics 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	06971463320032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172891

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: 2020-07-14
• Device Publish Date: 2020-07-06