Ice Heart

Basic Information

• Brand Name: Ice Heart
• Primary DI: 00735282447150
• Version / Model: 44715
• Company Name: MUNCHKIN, INC.
• Labeler DUNS: 787026855
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-14
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 6f8d3347-050b-45b2-9e83-3b9aecccc28a

Device Description

Cool gel that soothes gums Ridges to massage sore gums Easy-to-grasp heart shape

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: Yes
• PM Exempt: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKO	Ring, Teething, Fluid-Filled	Dental	872.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44272	Teething device, fluid-filled	A circular or cylindrical device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00735282447150	GS1

Customer Contacts

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