Berrcom

GUDID 10845717009871

Non-Contact Infrared Forehead Thermometer

VERIDIAN HEALTHCARE LLC

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• Primary Device ID: 10845717009871
• NIH Device Record Key: c410440c-8703-43ff-9e27-5298cc98fb56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Berrcom
• Version Model Number: 09-178
• Company DUNS: 830437997
• Company Name: VERIDIAN HEALTHCARE LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845717009874 [Primary]
GS1	10845717009871 [Package]; Contains: 00845717009874; Package: Master Carton [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: 2020-05-01
• Device Publish Date: 2020-04-23

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• 10845717009000 - HeathWise: 2021-05-13 HealthWise Forehead Infrared Thermometer
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• 00845717000185 - Heritage: 2020-08-03 Aneroid Sphygmomanometer, Child