Equinox International

GUDID 06947656112173

Guangzhou Berrcom Medical Device Co., Ltd

Infrared patient thermometer, skin

• Primary Device ID: 06947656112173
• NIH Device Record Key: 5d3b4487-dec6-44aa-80d8-0bebdb24f4a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equinox International
• Version Model Number: EQ-THERM03
• 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	06947656112173 [Primary]
GS1	16947656112170 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-09
• Device Publish Date: 2018-03-01

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