Evert-It

Basic Information

• Brand Name: Evert-It
• Primary DI: 00683693360004
• Version / Model: 36000
• Catalog Number: 36000
• Company Name: Mai/Genesis
• Labeler DUNS: 078873500
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-12
• Public Version: 1
• Public Version Date: 2023-09-20
• Public Version Status: New
• Public Device Record Key: 1938d6bf-9a2c-4718-8d8a-3cd74358f2c1

Device Description

Evert-It Nipple Enhancer

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: No
• 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
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	884.5150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38477	Breast pump, manual	A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00683693360004	GS1

Premarket Submissions

Submission Number	Supplement Number
K962828	000