XRGO

GUDID 18100211780193

Dongguan SIMZO Electronic Technology Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 18100211780193
• NIH Device Record Key: 168d5fdd-693a-4c5e-ba19-9dd97852e632
• 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

Customer Support Contacts

• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com
• Phone: +1.661.428.3210
• Email: nate@nvx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08100211780196 [Primary]
GS1	18100211780193 [Package]; Contains: 08100211780196; Package: [1 Units]; Discontinued: 2020-05-06; Not 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: 2020-05-14
• Device Publish Date: 2020-05-06

On-Brand Devices [XRGO]

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