The First Years Y7078A8

GUDID B268Y7078A81

Multi-Use Digital Thermometer

TOMY INTERNATIONAL, INC.

General-purpose patient temperature probe, reusable

• Primary Device ID: B268Y7078A81
• NIH Device Record Key: 37cd6d27-8990-4093-b2db-162b092a180a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The First Years
• Version Model Number: Y7078A8
• Catalog Number: Y7078A8
• 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	B268Y7078A80 [Primary]
HIBCC	B268Y7078A81 [Package]; Contains: B268Y7078A80; Package: Retail [1 Units]; In Commercial Distribution
HIBCC	B268Y7078A84 [Package]; Package: Inner [4 Units]; In Commercial Distribution
HIBCC	B268Y7078A89 [Package]; Contains: B268Y7078A84; Package: Master [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: 2025-09-30
• Device Publish Date: 2025-09-22

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