BBLOVE Infrared Thermometer

GUDID 06953775601467

Alicn Medical Shenzhen, Inc.

Infrared patient thermometer, skin

• Primary Device ID: 06953775601467
• NIH Device Record Key: 9a0a8106-3e2e-4a05-bdfd-619c8d5d8096
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BBLOVE Infrared Thermometer
• Version Model Number: AET-R842
• Company DUNS: 548040741
• Company Name: Alicn Medical Shenzhen, Inc.
• 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: 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	06953775601467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180207

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: 2022-03-07
• Device Publish Date: 2022-02-26

Devices Manufactured by Alicn Medical Shenzhen, Inc.

• 06953775660457 - BESTEK Arm Blood Pressure Monitor: 2024-10-29
• 06953775609203 - BBLOVE Arm Blood Pressure Monitor: 2024-09-30
• 06953775609210 - BBLOVE Arm Blood Pressure Monitor: 2024-09-30
• 06953775609227 - BBLOVE Arm Blood Pressure Monitor: 2024-09-30
• 06953775633345 - BBLOVE Arm Blood Pressure Monitor: 2024-07-30
• 06953775660297 - ERDPAA Arm Blood Pressure Monitor: 2024-07-15
• 06953775660105 - ERDPAA Arm Blood Pressure Monitor: 2024-04-19
• 06953775660112 - BBLOVE Arm Blood Pressure Monitor: 2024-04-19