The First Years Y7078A7

GUDID B268Y7078A71

Multi-Use Digital Thermometer

TOMY INTERNATIONAL, INC.

General-purpose patient temperature probe, reusable

• Primary Device ID: B268Y7078A71
• NIH Device Record Key: 2d6dd12b-d7cb-4ac5-b5d0-171dc2188ed1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The First Years
• Version Model Number: Y7078A7
• Catalog Number: Y7078A7
• Company DUNS: 065183758
• Company Name: TOMY INTERNATIONAL, 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: false
• Manufacturing Date: true
• 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
HIBCC	B268Y7078A70 [Primary]
HIBCC	B268Y7078A71 [Package]; Contains: B268Y7078A70; Package: Retai [1 Units]; In Commercial Distribution
HIBCC	B268Y7078A74 [Package]; Package: Inner Carton [4 Units]; In Commercial Distribution
HIBCC	B268Y7078A76 [Package]; Contains: B268Y7078A74; Package: Master Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851146

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: 2024-04-02
• Device Publish Date: 2024-03-25

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• B268Y7078A71: Multi-Use Digital Thermometer