Jonterking

GUDID 16947656114068

Guangzhou Berrcom Medical Device Co., Ltd

Infrared patient thermometer, skin

• Primary Device ID: 16947656114068
• NIH Device Record Key: 5b8bb85e-12e3-487d-aacf-9fb93a91894a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jonterking
• Version Model Number: JXB-195
• 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	06947656114061 [Primary]
GS1	16947656114068 [Package]; Contains: 06947656114061; Package: Cartoon [50 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: 2022-04-20
• Device Publish Date: 2022-04-12

On-Brand Devices [Jonterking]

• 16947656114068: JXB-195
• 16947656114051: JXB-182
• 16947656114075: JXB-178
• 16947656114174: JXB-178