Handy Solutions

GUDID 06951727601459

Shenzhen Changkun Technology Co., Ltd.

Infrared patient thermometer, skin

• Primary Device ID: 06951727601459
• NIH Device Record Key: 555ec019-560d-4c52-ae23-c245d423d06c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handy Solutions
• Version Model Number: CK-T1502
• Company DUNS: 554502671
• Company Name: Shenzhen Changkun 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06951727601459 [Primary]
GS1	16951727601456 [Package]; Package: BOX [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193253

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: 2022-10-06
• Device Publish Date: 2022-09-28

Devices Manufactured by Shenzhen Changkun Technology Co., Ltd.

• 06951727601879 - maguja: 2023-04-24
• 06951727601459 - Handy Solutions: 2022-10-06
• 06951727601459 - Handy Solutions: 2022-10-06