Summer Infant

Basic Information

• Brand Name: Summer Infant
• Primary DI: 00012914144541
• Version / Model: 14454
• Company Name: SUMMER INFANT (USA), INC.
• Labeler DUNS: 930830141
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-21
• Public Version: 4
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 714a362e-2947-4a54-9124-ea23d25602b4

Device Description

Health and Grooming Kit (Stick)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

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
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
Package	20012914144545	GS1	Master	12	In Commercial Distribution
Package	10012914144548	GS1	Inner	3	In Commercial Distribution
Primary	00012914144541	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -13 – 131 Degrees Fahrenheit