BP

GUDID 16947656116260

Guangzhou Berrcom Medical Device Co., Ltd

Infrared patient thermometer, ear

• Primary Device ID: 16947656116260
• NIH Device Record Key: ce45f6e0-1b94-4c33-9da9-71e1fd65566b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BP
• Version Model Number: ET107
• Company DUNS: 529391821
• Company Name: Guangzhou Berrcom Medical Device 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947656116263 [Primary]
GS1	16947656116260 [Package]; Contains: 06947656116263; Package: Cartoon [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213079

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: 2024-10-23
• Device Publish Date: 2024-10-15

Devices Manufactured by Guangzhou Berrcom Medical Device Co., Ltd

• 26947656112948 - COCOBEAR: 2025-10-07
• 76947656114442 - DormDoc: 2025-10-07
• 46947656117701 - BERRCOM: 2025-09-05
• 56947656115315 - BERRCOM: 2025-08-05
• 66947656116685 - Sprucely: 2025-08-04
• 16947656116260 - BP: 2024-10-23
• 16947656116260 - BP: 2024-10-23
• 56947656116251 - Berrcom: 2024-10-04
• 56947656116213 - Snomd: 2024-09-30