Temp Pal (Smart Thermometer Patch), Smart Temp

GUDID 04712977931060

Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.

iWEECARE Co., Ltd.

Wireless patient thermometer, reusable

• Primary Device ID: 04712977931060
• NIH Device Record Key: e945beb5-16bf-4f41-9646-0e5c3d07adfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temp Pal (Smart Thermometer Patch), Smart Temp
• Version Model Number: STP-MB01-1
• Company DUNS: 658869653
• Company Name: iWEECARE 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: true
• 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	04712977931060 [Primary]
GS1	14712977931067 [Package]; Package: Carton [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222588

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: 2024-03-26
• Device Publish Date: 2024-03-18