Amazon Basic Care

GUDID 00195515000406

Temple Touch Digital Thermometer

AMAZON.COM SERVICES LLC

Intermittent electronic patient thermometer

• Primary Device ID: 00195515000406
• NIH Device Record Key: 5fb93f80-fed8-49d1-9f97-36d786bea00f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amazon Basic Care
• Version Model Number: Model FHT6C
• Company DUNS: 128990418
• Company Name: AMAZON.COM SERVICES 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195515000406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032362

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: 2022-02-11
• Device Publish Date: 2022-02-03

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