The First Years

GUDID B268Y70514

TFY Rapid Read Underarm Thermometer

TOMY INTERNATIONAL, INC.

General-purpose patient temperature probe, reusable General-purpose patient temperature probe, reusable

• Primary Device ID: B268Y70514
• NIH Device Record Key: f1b25101-c135-4a77-94ff-ec0df939f813
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The First Years
• Version Model Number: Y7051
• 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	B268Y70510 [Primary]
HIBCC	B268Y70511 [Package]; Contains: B268Y70510; Package: Retail [1 Units]; In Commercial Distribution
HIBCC	B268Y70514 [Package]; Contains: B268Y70516; Package: Master Carton [4 Units]; In Commercial Distribution
HIBCC	B268Y70516 [Package]; Contains: B268Y70511; Package: Inner Carton [6 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-27

On-Brand Devices [The First Years]

• B268Y70514: TFY Rapid Read Underarm Thermometer
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• B268Y60531: Quiet Expressions Plus Rechargeable Pump - Double
• B268Y52880: Star Teether
• B268Y7078A61: Digital Thermometer
• B268Y7057A51: Health and Grooming Kit
• B268Y79571: Health and Grooming Kit
• B268Y7078A71: Multi-Use Digital Thermometer