XRGO

GUDID 10810021178056

Dongguan SIMZO Electronic Technology Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 10810021178056
• NIH Device Record Key: 29f83ee9-0f93-4698-a34f-8bb159d978a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XRGO
• Version Model Number: HW-F7
• Company DUNS: 544332470
• Company Name: Dongguan SIMZO Electronic 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: 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	00810021178059 [Primary]
GS1	10810021178056 [Package]; Contains: 00810021178059; Package: [1 Units]; In Commercial Distribution
GS1	20810021178060 [Package]; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173048

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: 2020-06-29
• Device Publish Date: 2020-06-20

On-Brand Devices [XRGO]

• 18100211780193: HW-F7
• 10810021178056: HW-F7