Prexiso

GUDID 28100211780176

Dongguan SIMZO Electronic Technology Co., Ltd.

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