Comfort Zone CLEAN

GUDID 10810021178285

Dongguan SIMZO Electronic Technology Co., Ltd.

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• Primary Device ID: 10810021178285
• NIH Device Record Key: 6d5bc8de-a05a-4bda-a5c1-1277a4fe299a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Zone CLEAN
• 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	00810021178288 [Primary]
GS1	10810021178285 [Package]; Contains: 00810021178288; Package: [1 Units]; In Commercial Distribution
GS1	20810021178299 [Package]; Package: [8 Units]; In Commercial Distribution
GS1	30810021178036 [Package]; Contains: 20810021178299; Package: [2 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: 2020-09-02
• Device Publish Date: 2020-08-25

Devices Manufactured by Dongguan SIMZO Electronic Technology Co., Ltd.

• 00810021174013 - NA: 2024-01-11
• 10810021174034 - NA: 2024-01-11
• 00810021171166 - SIMZO: 2021-07-28
• 00810021171173 - SIMZO: 2021-07-28
• 00810021171180 - SIMZO: 2021-07-28
• 00810021171197 - simzo: 2021-07-28
• 00810021171203 - SIMZO: 2021-07-28
• 00810021171210 - SIMZO: 2021-07-28