LINKTEMP

GUDID 16947656112989

Guangzhou Berrcom Medical Device Co., Ltd

Infrared patient thermometer, skin

• Primary Device ID: 16947656112989
• NIH Device Record Key: 735eb7db-dbb4-49e8-95ef-3fe0b0ebec8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINKTEMP
• Version Model Number: JXB-305
• 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	06947656112982 [Primary]
GS1	16947656112989 [Package]; Contains: 06947656112982; Package: Cartoon [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130231

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: 2020-07-24
• Device Publish Date: 2020-07-16

Devices Manufactured by Guangzhou Berrcom Medical Device Co., Ltd

• 16947656116260 - BP: 2024-10-23
• 56947656116251 - Berrcom: 2024-10-04
• 56947656116213 - Snomd: 2024-09-30
• 56947656116220 - Snomd: 2024-09-30
• 56947656116091 - Snomd: 2024-08-28
• 36947656116059 - Snomd: 2024-08-06
• 56947656115902 - Berrcom: 2024-07-25
• 16947656115829 - BERRCOM: 2024-06-20