The First Years Y7957

GUDID B268Y79571

Health and Grooming Kit

TOMY INTERNATIONAL, INC.

Infant care kit

• Primary Device ID: B268Y79571
• NIH Device Record Key: a47bd0ab-8072-4ad6-94eb-0ccbc1536996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The First Years
• Version Model Number: Y7957
• Catalog Number: Y7957
• Company DUNS: 065183758
• Company Name: TOMY INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	B26879570 [Primary]
HIBCC	B268Y79571 [Package]; Contains: B26879570; Package: Retail [1 Units]; In Commercial Distribution
HIBCC	B268Y79573 [Package]; Package: Inner Carton [3 Units]; In Commercial Distribution
HIBCC	B268Y79579 [Package]; Contains: B268Y79573; Package: Master Carton [12 Units]; In Commercial Distribution

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: 2024-01-26
• Device Publish Date: 2024-01-18

On-Brand Devices [The First Years]

• B268Y70514: TFY Rapid Read Underarm Thermometer
• B268Y62281: Quiet Expressions breast pump with Breastflow bottle
• 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