The First Years

Basic Information

• Brand Name: The First Years
• Primary DI: B268Y7078A70
• Version / Model: Y7078A7
• Catalog Number: Y7078A7
• Company Name: TOMY INTERNATIONAL, INC.
• Labeler DUNS: 065183758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-25
• Public Version: 1
• Public Version Date: 2024-04-02
• Public Version Status: New
• Public Device Record Key: 2d6dd12b-d7cb-4ac5-b5d0-171dc2188ed1

Device Description

Multi-Use Digital Thermometer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37340	General-purpose patient temperature probe, reusable	A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B268Y7078A71	HIBCC	Retai	1	In Commercial Distribution
Primary	B268Y7078A70	HIBCC
Package	B268Y7078A74	HIBCC	Inner Carton	4	In Commercial Distribution
Package	B268Y7078A76	HIBCC	Master Carton	6	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K851146	000