Snomd

GUDID 36947656116059

Guangzhou Berrcom Medical Device Co., Ltd

Infrared patient thermometer, skin

• Primary Device ID: 36947656116059
• NIH Device Record Key: 98a68b7f-e2d8-4c77-a731-3b2f77b13d8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Snomd
• Version Model Number: JXB-178
• 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	06947656116058 [Primary]
GS1	36947656116059 [Package]; Contains: 06947656116058; Package: Cartoon [80 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: 2024-08-06
• Device Publish Date: 2024-07-29

On-Brand Devices [Snomd]

• 56947656115384: JXB-183
• 56947656115360: DT008
• 56947656115346: DT007
• 36947656116059: JXB-178
• 56947656116091: ET003
• 56947656116220: JXB-302
• 56947656116213: JXB-301