Breathe Pure

GUDID 10810021178377

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

• Primary Device ID: 10810021178377
• NIH Device Record Key: dc3e67d9-5320-424b-a568-6488fbf58c37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breathe Pure
• 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: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com
• Phone: +86 15166110228
• Email: 15166110228@163.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021178363 [Primary]
GS1	10810021178377 [Package]; Contains: 00810021178363; Package: [1 Units]; In Commercial Distribution
GS1	20810021178428 [Package]; Package: [3 Units]; In Commercial Distribution
GS1	30810021178050 [Package]; Contains: 20810021178428; 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: 2020-12-24
• Device Publish Date: 2020-12-16

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