Smart Care

Basic Information

• Brand Name: Smart Care
• Primary DI: 00850010842325
• Version / Model: 84232-24
• Company Name: ASHTEL STUDIOS, INC
• Labeler DUNS: 148689180
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2023-09-20
• Public Version: 1
• Public Version Date: 2023-09-28
• Public Version Status: New
• Public Device Record Key: cbbbfa20-f9cb-4bd5-97c1-def148d8fb90

Device Description

Fisher-Price Healthcare Kit 6pcs: 1 x medicine dropper, 1 x medicine spoon, 1 x digital thermometer, 1 x nasal aspirator, 1 x emergency card, 1 nail clipper

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	878.4680	1
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10243	Infant care kit	A portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nail clippers. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850010842325	GS1
Unit of Use	50850010842320	GS1