SIMZO

GUDID 00810021171043

Dongguan SIMZO Electronic Technology Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 00810021171043
• NIH Device Record Key: 5258e571-2d47-4cfe-94ef-96669646650b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIMZO
• Version Model Number: HW-4
• 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	00810021171043 [Primary]

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: 4
• Public Version Date: 2020-10-26
• Device Publish Date: 2019-08-17

On-Brand Devices [SIMZO]

• 08100211710094: HW-F2
• 08100211710148: HW-F7
• 08100211710032: HW-3
• 08100211710131: HW-F6
• 08100211710124: HW-F5
• 08100211710117: HW-F4
• 08100211710100: HW-F3
• 08100211710087: HW-F1
• 08100211710070: HW-303
• 08100211710063: HW-302
• 08100211710056: HW-4S
• 08100211710049: HW-4
• 08100211710025: HW-2S
• 08100211710018: HW-2
• 10810021171033: HW-3
• 10810021171149: HW-F7
• 00810021171135: HW-F6
• 00810021171128: HW-F5
• 00810021171111: HW-F4
• 00810021171104: HW-F3
• 00810021171098: HW-F2
• 00810021171081: HW-F1
• 00810021171074: HW-303
• 00810021171067: HW-302
• 00810021171050: HW-4S
• 00810021171043: HW-4
• 00810021171029: HW-2S
• 00810021171012: HW-2
• 00810021171272: HW-F7
• 00810021171265: HW-F7
• 00810021171258: HW-F7
• 00810021171241: HW-F7
• 00810021171234: HW-F7
• 00810021171227: HW-F7
• 00810021171210: HW-F7
• 00810021171203: HW-F7
• 00810021171197: HW-F7
• 00810021171180: HW-F7
• 00810021171173: HW-F7
• 00810021171166: HW-B05