Prexiso

GUDID 28100211780176

Dongguan SIMZO Electronic Technology Co., Ltd.

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin

• Primary Device ID: 28100211780176
• NIH Device Record Key: d117562d-9b3b-4779-abfb-371d880ed584
• Commercial Distribution Discontinuation: 2020-04-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Prexiso
• 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	08100211780172 [Primary]
GS1	18100211780179 [Package]; Contains: 08100211780172; Package: [1 Units]; Discontinued: 2020-04-05; Not in Commercial Distribution
GS1	28100211780176 [Package]; Contains: 18100211780179; Package: [60 Units]; Discontinued: 2020-04-05; Not in Commercial Distribution
GS1	28100211780183 [Package]; Contains: 08100211780172; Package: [6 Units]; Discontinued: 2020-04-05; Not in Commercial Distribution
GS1	38100211780173 [Package]; Contains: 28100211780183; Package: [10 Units]; Discontinued: 2020-04-05; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-17
• Device Publish Date: 2020-04-05

On-Brand Devices [Prexiso]

• 28100211780176: HW-F7
• 10810021178049: HW-F7