Equate

GUDID 16947468554809

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Infrared patient thermometer, ear

• Primary Device ID: 16947468554809
• NIH Device Record Key: 5b9985ca-e236-4e44-b2a6-6355bb6e34a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equate
• Version Model Number: EQ-HW-EC-250-DI
• Company DUNS: 529903321
• Company Name: Shenzhen Belter Health Measurement and Analysis 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	06947468554802 [Primary]
GS1	16947468554809 [Package]; Contains: 06947468554802; Package: 10pcs/box [1 Units]; In Commercial Distribution
GS1	26947468554806 [Package]; Package: 72pcs/box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140681

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: 2020-05-04
• Device Publish Date: 2020-04-24

Devices Manufactured by Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

• 16947468500363 - RITE AID: 2023-09-28
• 16947468500356 - Bytech: 2023-07-04
• 16947468500349 - RITE AID: 2023-06-05
• 16947468500332 - NO: 2023-05-31
• 16947468500325 - Bluedot: 2023-04-06
• 16947468500318 - CARE TOUCH: 2022-11-22
• 16947468500295 - biotricity: 2022-08-26
• 16947468500301 - biotricity: 2022-08-26