Mommy Matters

Basic Information

• Brand Name: Mommy Matters
• Primary DI: 00850047439147
• Version / Model: MM-9000
• Company Name: Joylux, Inc.
• Labeler DUNS: 079956040
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-04
• Public Version: 1
• Public Version Date: 2025-03-12
• Public Version Status: New
• Public Device Record Key: f0989321-4a2e-476c-b2c0-11010702c99a

Device Description

NeoHeat

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGZ	Heater, Perineal, Direct Contact	Obstetrics/Gynecology	884.5390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33594	Perineal warmer	A device designed to apply heat, by direct contact or from a radiant source, to the surface of the perineum (the area between the vulva and the anus). It is intended to help to soothe the perineum after an episiotomy (a surgical incision into the perineum and vagina to prevent traumatic tearing during childbirth).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850047439147	GS1