Fever Thermometer

GUDID 00817746021325

BETTER BASICS, INC.

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• Primary Device ID: 00817746021325
• NIH Device Record Key: dd4f8990-18a9-4c16-b006-482659a93bcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fever Thermometer
• Version Model Number: MP-IRT450
• Company DUNS: 013029698
• Company Name: BETTER BASICS, INC.
• 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: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817746021325 [Package]; Contains: 00817746025552; Package: [100 Units]; In Commercial Distribution
GS1	00817746025552 [Package]; Contains: 00817746026665; Package: [1 Units]; In Commercial Distribution
GS1	00817746026665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131243

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: 2018-07-06
• Device Publish Date: 2017-09-15

Devices Manufactured by BETTER BASICS, INC.

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• 00817746020038 - blood pressure monitor: 2019-11-08
• 00817746020069 - blood pressure monitor: 2019-11-08
• 00817746020090 - blood pressure monitor: 2019-11-08
• 00817746020120 - blood pressure monitor: 2019-11-08
• 00817746020151 - Pulse oximeter: 2018-07-06
• 00817746020182 - Pulse oximeter: 2018-07-06
• 00817746020212 - Pulse oximeter: 2018-07-06